Category Archives: FDA Policy

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

FDA Needs Communications Expert Support

On October 3, FDA’s Center for Devices and Radiological Health (CDRH) issued a press release entitled “FDA outlines plans for an outside network of scientific experts“.  The release states that the purpose of the effort is to “plan to create … Continue reading

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

FDA Making Transparency Increasingly Clear

This week a number of people took note when the FDA announced the issuance of a report that outlined eight new proposals to increase transparency by allowing greater access to the agency’s compliance and enforcement data.  The eight proposals are … Continue reading

Posted in Advisory Committee Prepapartion, FDA Policy | Comments Off