Category Archives: FDA Policy

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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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

New Study on U.S. Drug Shortages Calls for Establishment of Early Warning System

For some time now, there have been shortages in the supply of key drugs, many of which have been key treatments for patients undergoing therapy for extremely serious and life-threatening conditions.  The FDA has developed a page on its website … Continue reading

Posted in Current Affairs, FDA Policy | 1 Comment