FDA promises 'elevated' new drug approvals: report by Arlene Weintraub Wednesday, July 10, 2019 The FDA's Janet Woodcock promised that the agency's recent enthusiasm for new drug approvals would continue, with caveats.
As recalls wear on, FDA calls 40 'sartan' meds carcinogen-free by Kyle Blankenship Friday, April 5, 2019 The FDA declared 40 generic hypertension drugs free from the three potentially carcinogenic compounds that cropped up in the "sartan" class.
Gottlieb throws his weight behind continuous manufacturing by Eric Palmer Wednesday, February 27, 2019 The FDA has issued guidance on continuous manufacturing and is allocating $58 million to move forward advanced manufacturing processes.
FDA commissioner: U.S. generic drugs are safe and effective by Eric Palmer Monday, February 25, 2019 FDA Commissioner Scott Gottlieb, M.D., again turned to Twitter to defend the quality of the U.S. drug supply and the agency’s record of keeping it safe.
FDA's aggressive move on tainted 'sartan' leads to shortages by Eric Palmer Monday, January 28, 2019 Recalls of tainted 'sartan' products have led to shortages and led the FDA to balance exposure versus going without a medication.
FDA turnabout lets generics makers keep shield against lawsuits by Eric Sagonowsky Friday, December 14, 2018 Generic drug makers scored a win at the FDA as the agency changed its mind on giving them responsibility to update their labels.
FDA lays out new manufacturing inspection blueprint by Eric Palmer Tuesday, September 5, 2017 The FDA is reorganizing its manufacturing inspections, saying the new system should speed drug approvals and reduce surprises for drugmakers.
