The FDA has finalized its guidance on the use of electronic health records (EHR) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.…
In its efforts to develop new guidances, the FDA is seeking information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCP) and the best way…
Merck announced that its investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints. Source: Drug Industry Daily
Prescription benefit managers (PBM) use drug rebate payments to promote use of brand name drugs instead of generics, says a report released ahead of a House Committee on Oversight and…
The FDA offers recommendations on what’s needed to support chemistry, manufacturing and controls (CMC) changes for biosimilars and interchangeable biosimilar products, in a new draft guidance. Source: Drug Industry Daily
This edition of Quick Notes focuses on FDA approval for Roche’s Vabysmo, reintroduction of Susvimo following a recall, EC approval of Dupixent and Samsung Bioepis’ Soliris biosimilar. Source: Drug Industry…
The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report. Source: Drug Industry Daily
The Department of Justice’s complaint against Regeneron that the company’s single cash-or-credit price is a violation of the False Claims Act “is not only incompatible with the text of the…
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…
The FDA has issued a final guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies, including deciding whether and when to conduct the study, designing…