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chemistry, manufacturing and controls (CMC) changes for biosimilars and interchangeable biosimilar products, in a new draft guidance.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…
Following a Form 483 inspection report that Jiangsu Hengrui Pharmaceuticals of China was found to be storing sterile injectable drugs bound for the US market on corroded metal racks which…
FDA has established a new Rare Disease Innovation Hub (the Hub) to leverage cross-agency expertise and spur the development of treatments for rare diseases, CDER Director Patrizia Cavazzoni and CBER…
The Mark Cuban Cost Plus Drug Company is offering a low-cost, imported penicillin product after being given temporary approval by the FDA to help ease the ongoing shortage of Pfizer’s…
This week, the FDA published final guidance on drugs for treatment of partial onset seizures, combination product user fees, radiolabeled mass balance study clinical pharmacology considerations. Draft guidance was issued…