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A final guidance published Dec. 17 indicates the FDA will limit the kinds of questions generic drug sponsors may submit to the agency to get feedback during drug development. Read More
A Florida manufacturer of over-the-counter drug products had high microbial counts in water it used for manufacturing among other significant violations of current good manufacturing practice, according to an FDA warning letter to the firm. Read More
Warnings of international crime targeting the yet-to-be-approved COVID-19 vaccines are getting louder, with the international police agency Interpol issuing an Orange Notice, which warns of an “imminent threat to public safety.” Read More
By the end of 2022, drug, device and biologic product sponsors that are required to submit a risk evaluation and mitigation strategy (REMS) will have to do so electronically, the FDA said in a final guidance issued late last month. Read More
The FDA is working on a report tied to a two-day meeting held in December to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. Read More
The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Read More
Hacker groups in Russia and North Korea continue to mount cyberattacks against companies working on COVID-19 vaccines and treatments, Microsoft warned, calling on governments to take action against them. Read More
Owen Biosciences, an over-the-counter drug manufacturer in Baton Rouge, La., drew a Form 483 inspection report from the FDA detailing observations about good manufacturing practices at the company’s facility. Read More
An FDA inspection of Romark Global Pharma’s Manati, Puerto Rico drug manufacturing facility revealed problems with contamination of drug products and equipment. Read More
UCSF Radiopharmaceutical Facility drew a lengthy inspection report from the FDA for failing to fully investigate out-of-specification results and other quality lapses. Read More
Pro Breath MD and Vibrant Health Care: The FDA has issued a flood of warning letters during the pandemic to crack down on marketers of sham COVID-19 treatments. Read More
The FDA published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More