We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
FDA Commissioner Scott Gottlieb released a letter that tried to raise his staff’s morale, noting that “it’s in times of challenge and uncertainty that the public needs us most.” Read More
Eli Lilly said it supported giving consumers more information but claimed the CMS plan might “create more confusion than clarity for patients.” Read More
A group of opioid manufacturers and distributors filed for a gag order against Ohio Attorney General Mike DeWine and two other prominent attorneys in connection with multidistrict opioid litigation. Read More
CDER released its latest annual report on drug safety priorities on Tuesday, detailing how it approached drug safety in 2018 — including how it handled the valsartan impurity crisis. Read More
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