The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

More... http://pharmacy-education.blogspot.com/2011/01/drug-approvals-slipped-in-2010-some.html

References-

http://www.bloomberg.com/news/2010-12-30/new-drug-approvals-fell-in-2010-as-safety-concerns-slow-u-s-fda-decisions.html

http://online.wsj.com/article/SB10001424052748704543004576052170335871018.html?mod=googlenews_wsj

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Dr. Shruti Bhat, is a Leader in Pharmaceutical R&D and QbD specialist presents few salient points regarding the latest quality systems expected by regulators from the life science, more particularly pharmaceutical industry. But first, a brief chronology of evolution of quality systems. 

Definitions and scope of quality systems in pharmaceuticals has evolved over a period of time. The “Thalidomide babies tragedy” prompted the concept of continuous or cGMP. With cGMP came into existence the concept of Quality Assurance or “Zero defect”. QA advocated that quality cannot be created at the end of processing, but has to be in-built into a product at every step of manufacturing process. 

Further improvements in quality systems throughout the 1990’s and beyond brought about concepts of internal audits, documentation and validations. Y2K improved quality systems further...introduced 21CFR part 11 compliance measures. Year 2010 and beyond promises further refinement in quality systems- Quality-by-Design (QbD). 

What is quality by design?...at http://www.qa-expert.com/2010/06/quality-systems-approach-to.html 

Disclaimer- The content of this article is intended to provide a general guide to the subject matter.

A detailed whitepaper on “Introduction of Quality-by-design in Pharmaceutical industry” is available FREE of charge with the author. Interested parties may contact.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Shruti has initiated a new blog Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

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USFDA received 25 percent more reports of adverse drug events in 2008 compared with 2007,  according to a new QuarterWatch report from the Institute for Safe Medication Practices. In 2008, the FDA received reports of nearly 100,800 cases of serious injury related to drug use...compared with 80,600 in 2007,  the largest over a one-year period since the FDA began collecting data in 1998.
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