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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
Civica Rx — the nonprofit drug company created by hospital groups to help deal with high generic drug prices and shortages — announced on Monday that it’s on track to launch more than 14 hospital-administered generic drugs this year and has added 12 new member groups representing 250 hospitals. Read More
The FDA will run out of funds for PDUFA reviews in “about one month,” FDA Commissioner Scott Gottlieb tweeted as the federal shutdown entered its third week. Read More