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As the partial government shutdown kept the FDA’s routine activities on hold, FDA Commissioner Scott Gottlieb on Tuesday announced the creation of a new office to help streamline the agency’s review of new drugs. Read More
The FDA granted a petition to add warning labels for hypnotic drugs on the risk of injury from falling, but shot down calls for tougher risk assessments by drug sponsors. Read More
The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the recent FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C. Read More
The FDA withdrew a proposed rule in December that would have allowed generic drugmakers to independently update and distribute revised labeling to reflect new safety data. Read More
The FDA issued final guidance on data integrity and compliance with current good manufacturing practices. Commissioner Scott Gottlieb said the agency revised its recommendations in response to stakeholder requests for more details. Read More
Some of the FDA’s regulatory and compliance activities — including routine inspections — were placed on hold because of the partial government shutdown that began on Dec. 22 and continued into the new year. Read More
The FDA revised its recommendations on current good manufacturing practices for drug compounding outsourcing facilities, drawing a line between agency requirements for sterile and nonsterile drug products and outlining practices to protect against contamination. Read More
A Vermont initiative to allow importation of drugs from Canada could save millions of dollars each year, but it’s not clear that those savings would exceed the program’s costs, according to a report by the state’s Agency of Human Services (AHS). Read More