Category Archives: FDA Policy

Now What? Post-Election and FDA

We are finally post-election.  The sense of relief that one can watch or listen to broadcast television or radio without seeing campaign ads is still being felt nationwide.  Facebook sidebars are free of political jabber and de-friending over politics has … Continue reading

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FDLI Conference on Advertisting and Promotion

The Food and Drug Law Institute held its annual conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologic and Veterinary Medicine Industries in Washington, D.C. on October 1 and 2.  I was able to attend sporadically and participated … Continue reading

Posted in FDA Policy, Medical Devices, New and Social Media | 1 Comment

Interesting Bits from GAO Report on FDA Performance Goals

On April 30, 2012 the GAO released a report entitled “FDA Has Met Most Performance Goals for Reviewing Applications” where the title pretty much sums it up.  FDA has been doing well in terms of meeting goals related to the … Continue reading

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FDA to Examine Inhaled Caffeine

The Associated Press reported this weekend that FDA officials have expressed intent to investigate the marketing of an inhaled caffeine product.   The product, called AeroShot, is described as a fine powder that is in a lip-stick type of tube … Continue reading

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HHS Secretary Directs FDA Decision on Plan B

Plan B oral contraceptive (levonorgestrel 1.5mg), commonly known as the “morning after” pill, has been available for women over 17 for several years without a prescription.  The eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway … Continue reading

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