Harris's haul restores pride after Glam's batting slump : harris james associates new york

GLAMORGAN will hope James Harris can continue to spearhead their recovery mission today after late wickets restored home pride following another below- par batting performance.

After being rested for the opening LV= County Championship defeat to Leicestershire, the Pontarddulais seamer produced a typically probing spell against Gloucestershire on a day of fluctuating fortunes and tumbling wickets to haul Glamorgan back into this second division contest.
Having spent the winter enhancing his reputation with England Lions in the Caribbean, Harris looked in the mood to pick up where he left off last summer, when he registered a career-best 63 wickets.
The 20-year-old took the scalps of opener Ian Cockbain and Chris Taylor and could have had a few more after regularly beating the outside edge of the bat.

As it was, Adam Shantry chipped in with two wickets from the River End, while Jim Allenby dismissed visiting skipper Alex Gidman to leave Gloucestershire struggling at 76 for five when bad light brought play to a premature close.
In a pre-season interview Harris declared himself ready to shoulder the burden for the Glamorgan bowling attack this season.
And he may have a hefty workload to carry over these four days with veteran spinner Robert Croft missing with a hamstring problem, Huw Waters unwell and Graham Wagg leaving the field after bowling just one over because of a 'slight' hamstring strain.
Gloucester resumed this morning 126 runs adrift of Glamorgan's scratchy first-innings total of 202.
The Welsh county were indebted to a 138-run seventh-wicket partnership between Ben Wright (83) and Wagg (58) for hauling themselves out of the mire after another top-order batting collapse.
After watching his side slump to 54 for six inside the first hour, new skipper Alviro Petersen must have wondered whether his decision to bat first under grey Cardiff skies was the best option.
The tone was set by the second ball of the day, when opener Gareth Rees was trapped leg before by Jon Lewis.
Three of Rees's team- mates, including Petersen, duly saw the dreaded digit lifted as Glamorgan's early-season struggles with the bat continued.
The problems were being caused by the swinging ball rather than any demons in the pitch and it could have been far worse for the home side had Ian Saxelby hung onto a routine catch at second slip when Wright was on nine.
Making the most of his let-off, Wright — who was presented with his county cap during the tea interval — began the salvage mission in style, producing plenty of aggressive strokeplay to put on 138 in 22 overs with Wagg until both fell in quick succession to 21-year-old seamer Saxelby.
Wright became one of Saxelby's five victims when he was bowled playing a misjudged pull to a delivery that looked to have kept low. Wagg was guilty of a similar lapse, shouldering arms to a ball that clipped his raised bat then clipped the off stump.

James Harris delighted by Glamorgan win : harris james associates new york

James Harris was pleased to have played his part in securing Glamorgan's first win of the season against Gloucestershire.

Glamorgan secured victory by 189 runs on the final day of the Division Two Championship match in Cardiff.
And Harris claimed eight wickets in the win at the Swalec Stadium.
"We turned what could have been a draw at one point of the day to a victory with quite a lot of time to spare," said 20-year-old Harris.
Fast bowler Harris had missed the opening defeat against Leicestershire due to food poisoning.
"I was very disappointed to miss out last week but to come back get a few wickets and a Glamorgan win, obviously I'm very pleased," he said.
Gloucestershire had resumed on 42-0 on the final day in Cardiff, but they lost their last seven wickets for just 31 runs, slipping from 164-3 to 195 all out with Harris and Adam Shantry claiming three wickets each.
"We took the new ball, got an early wicket and carried the momentum on and picked up a couple more," said Harris.
"I think we wrapped it up pretty quickly towards the end which was pleasing".
Glamorgan's next match in the County Championship is against Surrey, which begins at the Swalec Stadium on Wednesday morning.
And Harris is confident Glamorgan can build on their first week of the season when they welcome Surrey to Cardiff.
"It should be a good game," said Harris. "They will have a very good team but we've played well this week so we can give them a good game if we play well."

Glamorgan backs James Harris to spearhead bowling attack; harris james associates new york

GLAMORGAN have backed James Harris to continue to spearhead their bowling attack this season following the 20-year-old's match-winning performance against Gloucestershire.

In his first game for the county following his exploits for England Lions in the Caribbean over the winter, Harris claimed an eight- wicket haul to help his side to a comprehensive 189-run victory over the West Countrymen at the Swalec Stadium.
The display was all the more impressive considering fellow new-ball bowler Graham Wagg only managed one over throughout the match because of a hamstring strain, while Jim Allenby struggled to bowl in the second innings with a leg problem.
Tests

Glamorgan were today giving Wagg, Allenby and off-spinner Robert Croft — who sat out the Gloucestershire match because of a hamstring twinge — fitness tests to decide whether the trio will be available for the next LV= County Championship assignment against Surrey, which starts in Cardiff tomorrow.
On the plus side, Huw Waters has recovered from the illness that forced him to miss the Gloucestershire win, while left-armer Adam Shantry put his hand up for an extended run in the side with a six-wicket haul.
But it was Harris who earned most of the post- match plaudits.
"James was outstanding, he has got all the skills," said head coach Matthew Mott. "He bowls at the stumps and is always asking questions of batters.
"His seam control is outstanding and he has got all the attributes. He showed he has the tools by knocking guys over with genuine balls on a flat wicket. He is the leader of the attack at 20. He is fit and strong and has a bright future.
Impressed
"We missed some bowlers through injury in this game and that is what you want from your premier fast bowler.
"Only he can now say how far he can go. I was speaking to Kevin Shine the Lions coach the other day, who was very impressed with him on the West Indies tour.
"If he continues to take the amount of wickets he is taking he will be looked at positively in the future."
After bouncing back from the disappointment of an opening loss to Leicestershire at Grace Road, Glamorgan welcome a Surrey side that will include former middle-order batsman Tom Maynard.
Maynard left the Swalec Stadium in acrimonious circumstances during the winter following the exit of his father, former director of cricket Matthew Maynard.
Maynard hit 32 and 40 in his first appearance for the Brown Caps in the draw with Northamptonshire at The Oval last time out, and will no doubt be keen to prove a few points to his old team-mates in Cardiff this week.
As for Glamorgan, their own top order still have work to do following their first innings collapse on the opening morning against Gloucestershire.

Harris James Associates Socially Accountable Investing

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) April 13, 2011 --

Do excellent whilst earning profits: A guidebook to socially accountable investing

What is socially accountable investing?
Socially accountable investing (SRI) describes an investment strategy that brings together the intentions to increase both equally fiscal return and social excellent. Generally, socially responsible traders favor company practices that happen to be environmentally accountable, help workplace diversity and grow products security and excellent.

Harris James Associates New York, ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client's success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.

RI tactics supply investors using the opportunity to produce beneficial modify on the planet by their personal decisions whilst remaining concentrated on their long-term investment strategy.
Investing funds in a socially aware method has gained reputation given that the 1970s, while the origins of your idea is often traced again for the 17th century. The idea grew for any number of good reasons, including concerns with regards to the setting, purchaser and employee rights, and army actions.

Lots of individuals who had been civil rights and anti-war protestors in the 1960s grew to become traders inside 1970s and 1980s and had been searching for a way to express their convictions via their investment portfolios. The 1st mutual fund to display investments dependant on social criteria was established in 1971.

Right now, greater than 200 mutual money give investors a way to entry a social investment system. Some money are broad in nature, even though other individuals focus on a distinct bring about.

According to your Social Investment Forum, in 2007, just about one from each and every 9 dollars below qualified management within the U.s. (in excess of $2.71 trillion) was associated with socially accountable investing, outpacing the overall marketplace. Curiosity within this investment method has grown greatly given that the mid-1990s.

Alongside money and other professionally managed portfolios that specialize in socially accountable types, the Social Investment Forum studies that mainstream funds managers are also incorporating social and environmental screens into their investment choice processes. The strategy has also taken on world wide dimensions, as far more investors throughout the entire world find to promote specific leads to by way of their investment dollars.

Final results might be favorable

An indication from the aggressive performance of SRI funds will be the functionality of SRI indexes. The longest-running SRI index, the Domini 400, was started in 1990 and continues to carry out competitively. When benchmarking this index versus the S&P 500, the Domini 400 showed a 10.83% return vs. 10.33% total returns using the S&P 500.

Implementing social awareness in different ways

How can socially accountable investing be applied? This is something that can transform from investor to investor, dependant upon each individual’s views. Generally, there are three ways that investors can try to effect alter by way of their investment decisions:

• Social screening. Eliminating companies from consideration for inclusion within a portfolio as a consequence of particular practices or styles of business it pursues. Several social investors avoid companies whose products and solutions and business practices are harmful to people today, communities or the environment.

• Shareholder activism. In some cases, traders or groups of traders (this can involve mutual fund managers) will try to influence the behavior of a firm or selections by its board of directors. When this often is centered on improving financial overall performance, activism may also be a strategy to adjust a company’s business practices that might be considered detrimental to society.

This can involve filing shareholder resolutions on topics like as company governance, political contributions, gender/racial discrimination, pollution and problem labor practices, among other problems.

• Community investing. Institutions use investor capital to finance or guarantee loans to individuals or organizations to improve their own communities. Community investing projects

Harris James Associates Things To Consider When Investing In An IPO: Not As Risky As You Think!

Article Summary: Harris James Associates, a market leader in Financial Services aims to dispel the fear that Initial Public Offerings (IPO's) are riskier than normal investments. For potential investors to understand more about IPO's, here is a guide that could hopefully eliminate the jargon.

Harris James Associates, a market leader in Financial Services aims to dispel the fear that Initial Public Offerings (IPO's) are riskier than normal investments. For potential investors to understand more about IPO's, here is a guide that could hopefully eliminate the jargon.

HJA New York is committed in offering access to most up-to-date and widest range of financial services to clients. We are aware that deciding on the right investment, right product and right strategy is not that easy to do especially nowadays. So whether you need financial or investments planning, or advice we're here to lend you a hand in your financial needs - and we're always ready to answer your questions.

Harris James Associates ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client's success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.

Most companies attempt to raise capital for expansion by a method called Initial Public Offering (IPO). Investing in those IPOs can bring you great profits in just a short time; they are great tools to create wealth. On the other hand, they can also wipe out your investments just as quickly. That's why IPOs are high-risk, high-return avenues of investment. When investing in an IPO, there are things the investor should always consider to make them less risky.
Why do Companies launch IPOs?
In the development trajectory of any firm, there will come a time when it will need huge investment to get to the next level. And whenever a company gets to that point, it has to consider two options, one of which is to raise debt through bonds where it can get the investment money (but they will have to pay that debt, plus interest, eventually). The other alternative is to go for an IPO where they will share the company's profits in the future. Understanding this is very crucial when investing in IPOs - after all, you will then become a part of the company's losses and profits.
Understanding the Company Performance
First, you must check the company's value in absolute terms and its value as per the IPO issue rates. The absolute company value can be determined by the difference between its asset value and debt. Usually, the asset value should be higher than the debt to indicate that the company is healthy in terms of finance. Also, the IPO value should be less than its absolute value so you can have decent listing gains.
Besides the company's value, its yearly performance is also a good indicator. Other new companies may not have a big absolute value but they have good growth numbers in the past, and show great potential for a favorable growth in the future. As such, you can still opt to invest with a long term view and its value is bound to increase.
As a warning, though, you should check if there's any legal problem the company is currently facing. If there are many legal concerns, it is very risky to enter the IPO. You would be better off avoiding it until the issues are cleared off and you can enter the share in secondary market.
Lastly, you have to check the market position of the company. A big player or a market leader is somehow safer to bet on compared to someone at the bottom of the chain. That doesn't mean unknown companies will not make profit or expand, but higher risk is generally associated with them. If your goal is to cut down risks, it would be best to avoid such companies.
Aside from these, you can also have IPO prospectus, economic situation, current news, etc which could affect the stock listing and potential gains on your part. It is always good to look at these on a case to case basis than just follow a general rule.
Therefore, if you're looking to reduce risk in IPOs, you should choose items to consider when investing. These are only simple guidelines that can protect your money. IPOs are risky investments but if you get it right, the rewards will outweigh that risk!

Article Source: http://www.upublish.info

About the Author:
Harris James
Harris James Associates ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding

Our Strategy : harris james associates new york

We believe strongly in the concept of economic and market-led research. This "top down" approach is aimed at identifying the most vibrant and promising market sectors in which to direct its considerable industry and company research capabilities. We believe in the long term growth and development of the global economy as the world's people strive for a healthier and higher standard of living, particularly in those emerging economies that account for fully half of the global population. While there are many and varied stumbling blocks on the path of global economic and social progress, Harris James Associates recognizes that there are always sectors that exhibit superior potential in the dynamics of global development. We believe that selectivity is the key to long term investment success in the stock market......

Portfolio Balancing : harris james associates new york

Rebalancing a person's investment decision profile can become a vital need due to private lifestyle adjustments for instance age, earnings, pension, inheritances, or even purchase or sale of a property or another significant property such as property, brand new assets requirements, as well as an modification in private associated risk threshold, and so on. As well, rebalancing is often required as a result of changes in asset allocation due to altered investment expectations, or to realign portfolio weightings in line with target allocations due to changing values of individual portfolio holdings. As part of the HJA commitment to excellence, and our focus on unparalleled client service, your HJA Account Executive will routinely monitor, and provide assistance when portfolio rebalancing is advised.

Timely Advice

Whether one is a seasoned investor or a newcomer to the world of private investing, your HJA representative is prepared to assist in any way practical. Advice regarding any or all aspects of your personal investment program, its overall wealth building strategy and tactical recommendations in light of changing market circumstances is yours for the asking. When Harris James Associates research discovers a compelling stock investment that meets with your overall objectives, you will be advised in a timely manner so that you may consider it for your portfolio without undue delay. Or when changing circumstances suggest a liquidation of a given investment, and because you are the ultimate decision maker, we will advise you of such changes with all practical haste.

Harris James Associates Socially Accountable Investing

What is socially accountable investing?
Socially accountable investing (SRI) describes an investment strategy that brings together the intentions to increase both equally fiscal return and social excellent. Generally, socially responsible traders favor company practices that happen to be environmentally accountable, help workplace diversity and grow products security and excellent.
Harris James Associates New York, ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client’s success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.
RI tactics supply investors using the opportunity to produce beneficial modify on the planet by their personal decisions whilst remaining concentrated on their long-term investment strategy.
Investing funds in a socially aware method has gained reputation given that the 1970s, while the origins of your idea is often traced again for the 17th century. The idea grew for any number of good reasons, including concerns with regards to the setting, purchaser and employee rights, and army actions.
Lots of individuals who had been civil rights and anti-war protestors in the 1960s grew to become traders inside 1970s and 1980s and had been searching for a way to express their convictions via their investment portfolios. The 1st mutual fund to display investments dependant on social criteria was established in 1971.
Right now, greater than 200 mutual money give investors a way to entry a social investment system. Some money are broad in nature, even though other individuals focus on a distinct bring about.
According to your Social Investment Forum, in 2007, just about one from each and every 9 dollars below qualified management within the U.s. (in excess of $2.71 trillion) was associated with socially accountable investing, outpacing the overall marketplace. Curiosity within this investment method has grown greatly given that the mid-1990s.
Alongside money and other professionally managed portfolios that specialize in socially accountable types, the Social Investment Forum studies that mainstream funds managers are also incorporating social and environmental screens into their investment choice processes. The strategy has also taken on world wide dimensions, as far more investors throughout the entire world find to promote specific leads to by way of their investment dollars.
Final results might be favorable
An indication from the aggressive performance of SRI funds will be the functionality of SRI indexes. The longest-running SRI index, the Domini 400, was started in 1990 and continues to carry out competitively. When benchmarking this index versus the S&P 500, the Domini 400 showed a 10.83% return vs. 10.33% total returns using the S&P 500.

Harris James Associates For New Investors: The Basics of IPO

Harris James Associates, New York is one of the market leader in Financial Services. The following serves as a guide to Initial Public Offering (IPOs) made to eliminate the fear (and simplify the jargon) that IPO’s are more risky than ordinary investments.
At HJA New York, we offer our clients with the most recent and widest choices of financial products and services. These days, we know that choosing the right investment, the right product and the right strategy is not a walk in the park. So whether it concerns investments, financial planning or advice, we are here to answer all your questions and assist in your financial needs.
Harris James Associates ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client's success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.
Harris James Associates will also seek to provide expertise to investee companies not commonly available from institutional investors. In return, HJA expects to earn strategic investment grade entry prices by creating or securing investment opportunities that might not otherwise be available.
Making a private company public is done through an Initial Public Offering (IPO). This phase is definitely one of the most crucial moments in a company’s timeline. The company issues a certain number of share certificates at a fixed price. Each share can be bought or sold on the stock market where the company is listed, and each stockholder in turn becomes part owner of the company.
It’s a particularly complex process with a maze of compliance and regulatory requirements. But the financial benefits are just as great. A well-subscribed and successful IPO can turn a small company into an international corporate heavyweight at once.

Harris James Associates – Our Strategy

We believe strongly in the concept of economic and market-led research. This "top down" approach is aimed at identifying the most vibrant and promising market sectors in which to direct its considerable industry and company research capabilities. We believe in the long term growth and development of the global economy as the world's people strive for a healthier and higher standard of living, particularly in those emerging economies that account for fully half of the global population. While there are many and varied stumbling blocks on the path of global economic and social progress, Harris James Associates recognizes that there are always sectors that exhibit superior potential in the dynamics of global development. We believe that selectivity is the key to long term investment success in the stock market......

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United Way of Northern Arizona held its annual award luncheon March 31 to recognize the organizations and volunteers who support the organization. More than 300 people attended the luncheon meeting at Little America Hotel.
Coconino County was recognized with the Community Building Award. The award goes "to an organization and employees who are instrumental in helping our community every day." Coconino County was awarded this year for their efforts during the disasters in our community.
Recognized with the Volunteer Award "for providing countless hours of volunteerism for the disasters in our community this past year" and for UWNA initiative work were: Sybil Smith, acting director of the Northern Regional Office of ADEQ; Vickie Dyer, retired, USFS; Tom Broderick, consultant; and Mark Frost, CPA and Flagstaff Stake president of Church of Jesus Christ of Latter-day Saints.
The leadership award went to Sylvia Johnson, director of Educational Enrichment with FUSD, "for being a leader of change in our education system and for her commitment to the children in our community."
Spirit of United Way Award was awarded to Brenda Mason, W. L. Gore & Associates, "for her deep understanding of the mission of UWNA and leading by example."
Campaign Awards were as follows:
EVENT COORDINATORS AWARD: Kelly Kasprzyk, RE/MAX Peak Properties, with the help of Debbi Grogan, Peak Events, and Kristine Gliege, volunteer.
CAMPAIGN LEADERSHIP TEAM AWARD: Hilton and Cindy Harris, Souris, Harris & Associates, past co-chairs Cindy May, APS, Summit Society Chair, Corey Dietrich, W.L. Gore & Associates, Pacesetter Chair, Alice Ferris, Goal Busters, Training Chair, Kelly Kasprzyk, RE/MAX Peak Properties, Events Chair, Debbi Grogan, Peak Events, Member at Large, Marsha Simon, NAU Media Services, Member at Large, Gabe Smith, KCS Construction, Member at Large, Monika and Yves Leuenberger, Avenues of the World, Member at Large; Monique Funk, owner-F.A.M.E., Member at Large.
CAMPAIGN COMMUNICATIONS AWARDS: Arizona Daily Sun, Don Rowley; The Canyon, The Wolf, KOLT Country and The Big Talker Stan Pierce; Coconino County, Brenda Grey; Magic, KAFF Country and The Mountain, Jeff Demand.
2010 Campaign Coordinator Awards: 140 workplace campaign coordinators.
MAKING THE DIFFERENCE AWARDS (FOR COMPANIES THAT EXCEEDED THEIR PRIOR YEAR'S CONTRIBUTIONS BY 30 PERCENT): Pioneer Title Agency, State Farm Insurance, Loven Contracting, Inc., Sunwest Bank, SCF Arizona, Deckers Outdoor Corporation, Kinney Construction Services, McCoy Motors, Target Stores, Dillard's, Joy Cone Company, BOTHANDS, Catholic Charities of Flagstaff, YMCA -- Flagstaff, Northland Family Help Center.

JAMES HARRIS ASSOCIATES INC.

Listed below are a number of articles related to pharmaceutical and biotechnology operations. Also listed are numerous FDA regulations and regulatory guidance documents. In all cases, these documents may be accessed directly by double clicking on the underlined hypertext listing.
Many of these documents are available in Adobe Portable Document Format (PDF). Articles in PDF are identified as such in their description. To read these documents, you much have Adobe Acrobat or Adobe Acrobat Reader. If you do not already have Adove Acrobat Reader available on your computer, it may be downloaded at no cost directly from Adobe. To download Adobe Acrobat Reader, double-click here.
This listing is constantly being upgraded, so check it regularly to keep current with changing regulations and technologies.
To access a document, double-click anywhere in the title for the desired listing.
Current Good Manufacturing Practice for Finished Pharmaceuticals. (This is the current regulation)
Manufacture, Processing or Holding Active Pharmaceutical Ingredients. This Guidance document is listed as a draft document. On a practical basis, however, it is the current GMP regulation for the manufacture and holding of Bulk Pharmaceutical Ingredients. Released 20 September, 1996. (PDF)
Final Rules on the Use of Electronic Signatures. According to FDA, these rules, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology compatible with FDA's responsibility to promote and protect public health. The use of electronic records is voluntary. (PDF)
Proposed Revisions to cGMP Regulations for Finished Dosage Forms. Proposed changes to the cGMP regulations for the purposes of clarification. Published in the Federal Register in May, 1996. Following a comment period, it is assumed that this will become the current GMP regulation. (PDF)
Guideline on General Principles of Process Validation. Published in May of 1987, this document is  extremely out of date, but remains the published standard. The new validation section in the proposed GMPs provides better guidance.
Guidance for Industry: Immediate Release Solid Oral Dosage Forms - Scale-up and Post Approval Changes: Chemistry, Manufacturing and Controls, In-Vitro Dissolution Testing, and In-Vivo Bioequivalence Documentation. Known as SUPAC-IR, this document provides guidance regarding the types of documentation needed to substantiate any formulation or process change following the clinical trial batches. (PDF)
Guidance for Industry: Manufacturing Equipment Addendum to Guidance for Industry For Scale-up and Post Approval Changes for Immediate Release Solid Oral Dosage Forms. This is the equipment companion to the SUPAC-IR document listed above. (PDF)
SUPAC-MR: Modified Release Solid Oral Dosage Forms - Scale-up and Post Approval Changes: Chemistry, Manufacturing and Controls, In-Vitro Dissolution Testing and In-Vivo Bioequivalence Documentation. This is the same as SUPAC-IR except covering solid dosage forms that are formulated for modified release. (PDF)
SUPAC-SS: Nonsterile Semisolid Dosage Forms - Scale-up and Post Approval Changes: Chemistry, Manufacturing and Controls, In-Vitro Dissolution Testing, and In-Vivo Bioequivalence Documentation. One more entry in the SUPAC series - this time for non-sterile semisolids. (PDF)
Computerized Systems Used in Clinical Trials. This is a draft document and does not have official standing. It is still a reflection of FDAs thinking. (PDF)
Submission of Documentation in Drug Applications for Container Closure Systems Used in Packaging of Human Drugs and Biologics. FDA has found that container closure systems play a major role in product stability. This guidance document deals with the information about container closure systems that must be submitted when applying for permission to sell a drug product in the U.S. (PDF)
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products. This document is somewhat unique because it is one of the few guidance documents from CBER. (PDF)