Category Archives: FDA Policy

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

Posted in FDA Policy, Vitamins and Supplements | Comments Off

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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FDA Needs to Be Clear About Social Media

After an extended Thanksgiving break, there has been time to contemplate the upcoming end of the year. Two and a half years ago, the FDA stated that “it was not the medium, it was the message” to sum up its … Continue reading

Posted in FDA Image, FDA Policy, New and Social Media | 11 Comments