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The FDA is responding to frequently asked questions from generic drugmakers — including sponsors of drug-device combination products — on quality-related control correspondence with the agency in a draft guidance released yesterday. Read More
As of mid-September, the FDA had conducted just 295 domestic and 44 foreign pharmaceutical inspections for fiscal year 2021, falling far short of its “best-case” scenario projections. Read More
Reports of a vulnerability in the Blackberry operating system used in some pharmaceutical manufacturing equipment as well as in certain medical devices and device manufacturing has prompted the FDA to issue a cybersecurity alert. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) has issued its third untitled letter of the year to Deer Park, Ill.-based Eton Pharmaceuticals over advertisements for the company’s Alkindi Sprinkle (hydrocortisone) oral granule, a treatment for the pediatric hormone disorder adrenocortical insufficiency. Read More
Several drugmakers have offered suggestions in written comments to the FDA for revisions to the agency’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube. Read More
The FDA has finalized a guidance on one aspect of drug quality assessment: “Development and Submission of Near Infrared Analytical Procedures,” abbreviated NIR. Read More
The FDA observed a variety of quality issues during inspections of four drug facilities, including inadequate environmental monitoring, reviews of batch records, non-microbial contamination and — in one case — the lack of a quality unit. Read More
Farmakeio Outsourcing of Southlake, Tex., drew a warning letter from the FDA on Aug. 3 for quality issues observed during an inspection in 2019. Read More
The FDA issued a warning letter to Syntec Pharma for failure to prevent cross-contamination and for other good manufacturing practice lapses at its drug facility in Farmingdale, N.Y. Read More
Japanese drugmaker Toyobo failed to adequately investigate why batches of a sterile injectable drug it makes were repeatedly contaminated with particles, the FDA said in a warning letter to the company. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is setting up a new board to strengthen pharmaceutical supply-chain monitoring in the wake of COVID-19-related drug shortages. Read More
The FDA’s ability to monitor drug facility compliance in fiscal year 2020 was significantly impacted by COVID-19, with only 745 inspections completed for the year vs. 1,367 in fiscal 2019. Read More