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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
Eli Lilly and Boehringer Ingelheim have secured another FDA approval for blockbuster diabetes drug Jardiance (empagliflozin), announcing that the agency has OK’d the drug for treating adults with chronic kidney disease. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Despite positive and sometimes emotional testimony from diabetes patients, an FDA advisory committee voted Thursday to uphold CDER’s recommendation that the new drug application for ITCA 650 (exenatide in DUROS device), Intarcia Therapeutics’s diabetes drug/device combo, be denied approval. 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
Over the past week, the FDA issued final guidance on conducting clinical trials during major disruptions due to disasters and public health emergencies. Draft guidances were issued on biosimilar and interchangeable biosimilar labeling, demonstrating evidence of effectiveness with one clinical investigation, considerations for prescription drug use-related software, assessing drug manufacturing facilities identified in pending applications and formal meetings between the FDA and pharmaceutical sponsors or applicants. 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
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