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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. Read More
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.” Read More
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 recalls, a new report says. Read More
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, according to its latest annual report on Drug Safety Priorities. Read More
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. Read More
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. Read More
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, including a lack of validation for manufacturing processes and other problems. Read More
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). Read More
Fresenius Kabi Oncology (FKO) has agreed to plead guilty to hiding and destroying records prior to a 2013 FDA inspection and will hand over $50 million in fines and forfeiture, the U.S. Department of Justice revealed. Read More
In just over four months, drug manufacturers will experience a change in the FDA’s online adverse event report system to help the agency figure out what stage the product the adverse event is associated with has reached. Read More