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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
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
Eli Lilly has filed 10 patent lawsuits against wellness clinics, med spas and compounders and pharmacies for marketing and selling unapproved versions of the company’s blockbuster Type 2 diabetes drug, the glucagon-like peptide-1 (GLP-1) receptor agonist Mounjaro (tirzepatide). Read More
The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA. Read More
Medline Industries’ recall of 18,000 saline solution vials due to being non-sterile has been deemed as class 1 by the FDA, the most serious type of recall, because use of the device may cause serious injuries or death. Read More
