The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council…
Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination…
As U.S. vaccinations against COVID-19 gain momentum, health officials are using new tools to gather postmarket safety data, including a new early warning system called V-Safe. Source: Drug GMP Report
The FDA announced that it is developing guidance on compounding drugs during the COVID-19 pandemic to protect patients from “unsafe, ineffective and poor-quality compounded drugs, while preserving access for patients.”…
Drug recalls in 2020 climbed to 344, a 2.4 percent increase from the previous year, although that small increase was overshadowed by the amount of drugs actually impacted by the…
Like other parts of the FDA, the Center for Drug Evaluation and Research had to scramble last year to address COVID-19 while not losing sight of its other important tasks,…
Alembic Pharmaceuticals, a sterile drug manufacturer in Gujarat, India, drew a Form 483 inspection report from the FDA with five observations following a Jan. 28 – Feb. 6 inspection. Source:…
A Government Accountability Office (GAO) review of COVID-19 vaccine development efforts found that vaccine producers are facing significant manufacturing hurdles as they scale up operations. Source: Drug GMP Report
Allay Pharmaceuticals, a contract drug manufacturer in Hialeah, Florida, drew a warning letter from the FDA arising from a May 5-15, 2020 inspection in which investigators found serious quality lapses,…
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to AcelRx Pharmaceuticals over false and misleading claims it made for its oral opioid Dsuvia (sufentanil). Source: Drug…