December 7, 2011
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 →
November 28, 2011
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 →
November 14, 2011
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 →
October 11, 2011
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 →
October 5, 2011
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 →