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FDA draft guidance on non-inferiority clinical trials

Reed Smith LLP
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USA
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March 15 2010

FDA has released a draft guidance document addressing the interpretability of non-inferiority (NI) clinical trials, as well as the proper approaches for determining the NI margin and analyzing results

GAO report calls for increase in FDA criminal prosecutions of company executives

Reed Smith LLP
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USA
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March 15 2010

The GAO recently issued a report entitled "Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations," at the request of Senate Finance Committee Ranking Republican Charles Grassley

FDA requests comments on increasing transparency in the agency

Reed Smith LLP
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USA
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March 15 2010

As part of the Obama Administration's efforts to increase transparency in government, FDA is soliciting comments on ways to increase transparency between FDA and regulated industry

FDA’s emerging internet policy: themes and recommendations from public hearing on promotion of FDA-regulated medical products using the internet and social media tools

Reed Smith LLP
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USA
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November 27 2009

Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications

FDA seeks comment on transparency proposals

Reed Smith LLP
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USA
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May 25 2010

FDA is rolling out phase II of the FDA's Transparency Initiative with the issuance of 21 draft proposals intended to expand disclosure of information while maintaining confidentiality of trade secrets and individually identifiable patient information

FDA and NIH launch safety reporting website

Reed Smith LLP
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USA
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May 25 2010

The FDA and the National Institutes of Health (NIH) have launched a website, called the Safety Reporting Portal (SRP), intended for the reporting of certain pre- and post-market safety data

FDA guidance on medical device voluntary audit report submission program

Reed Smith LLP
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USA
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May 25 2010

FDA has issued draft guidance on the implementation of Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA

FDA workshop on medical device interoperability (Jan. 25-27)

Reed Smith LLP
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USA
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January 20 2010

An upcoming FDA public workshop will focus on safe and effective interoperable medical devices

FDA guidance document: planning for the effects of high absenteeism to ensure availability of medically necessary drug products

Reed Smith LLP
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USA
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January 13 2010

The FDA has issued a guidance document seeking to encourage the creation of contingency production plans for the manufacture of medically-necessary drug products and their components during emergencies that result in high absenteeism at production facilities

FDA issues warning letters to web site operators

Reed Smith LLP
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USA
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December 4 2009

On November 19, 2009, FDA completed a coordinated and collaborative international effort intended to curb illegal actions involving medical products sold via the internet

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