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The European Parliament and the European Medicines Agency (EMA) have agreed upon a regulation — updating a newly 20-year-old model — to modernize and simplify application fees the EMA collects. Read More
The Institute for Clinical and Economic Review (ICER) and the Peterson Health Technology Institute (PHTI) have partnered to assess digital health technologies (DHTs) against the standards that devicemakers should meet when generating early studies for their products. Read More
The FDA issued a complete response letter (CRL) to Coherus Biosciences on its BLA for a biosimilar of Neulasta (pegfilgrastim) solely due to an ongoing review of inspection findings at a third-party filler, the company said. Read More
The frequent electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance making recommendations for cybersecurity information to be submitted with premarket applications to CDRH and CBER. Read More
The FDA has no obligation to educate companies about what is and isn’t fair game during an inspection and there is no equivalent of a “Miranda warning” that cops must give when detaining individuals, says inspections expert David Chesney, principal of DL Chesney Consulting. Read More
As lawmakers fail to reach a deal to extend funding past the critical deadline of Sept. 30, the possibility of a government shutdown looms, threatening operations at the FDA and other government agencies. Read More
Novartis’ recall of one lot of its Sandimmune oral solution (cyclosporine) due to crystal formation has been deemed a class 1 recall by FDA, the most serious type of recall, because use of the drug may cause serious injury or death. Read More
The FDA smacked Novo Nordisk, producer of blockbuster weight loss drug semaglutide, the active ingredient in Wegovy and Ozempic, for quality control deficiencies discovered at its Clayton, N.C., plant, including microbiological contamination, following an inspection conducted in May 2022. Read More
Companies selling unapproved biologics products is a major ongoing concern for the FDA’s CBER, says an agency consumer safety expert, speaking at the 2023 PDA/FDA Joint Regulatory Conference on Wednesday. Read More