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Manufacturers of drugs, biologics and medical devices should be harnessing real-world data (RWD) at the postmarket stage, not just to support regulatory compliance but to generate ideas for innovative new products or indications, according to a former FDA official. Read More
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, provides his perspective on the likely direction of health product policies after the presidential election in November. Read More
The FDA issued six Warning Letters — to sellers including Amazon and Walmart — and created a drug safety page concerning sales of chemical skin peel products due to risk of serious skin injuries. Read More
This Q and A is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
Kaleo received an “untitled letter” from the FDA Office of Prescription Drug Promotion (OPDP) because one of the company’s social media posts for Auvi-Q (epinephrine injection) does not include any risk information about the drug. Read More
The FDA has posted six user fee schedules for FY 2025 on the Federal Register showing increases of up to 44 percent — the highest being for biosimilars. Read More
FDA recently added resources for the 2023 guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” to its Guidance Snapshot Pilot Program webpage. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has declined to recommend approval of Eisai’s Leqembi (lecanemab) for treatment of early Alzheimer’s disease, citing concerns over the drug’s safety. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes features announcements of Lilly’s acquisition of Morphic, a licensing agreement between SK Biopharmaceuticals and Full-Life Technologies, Agilent’s purchase of Biovectra and Cook Technologies sale of its IVF and ART business. Read More
Brassica Pharma, a maker of sterile semi-solids, received an FDA Warning Letter for failure to test every batch for sterility as well as fabrication of test results for batches not tested, among other violations. Read More
Despite another attempt by Ipsen Biopharmaceuticals to regain market exclusivity for its injectable neuroendocrine tumor drug Somatuline Depot (lanreotide), an appeals court has ruled once more in favor of the FDA. Read More