FDA 8/24 sends a Warning Letter to a Zimmer Biomet subsidiarys manufacturing facility in Warsaw, IN over GMP issues documented in an April inspection....
Pfizer petitions FDA to issue a guidance document to clarify appropriate sponsor communications about the nature and properties of biosimilar products...
FDA Review post the Federal Register notices for the week ending 8/24/2018.
FDA Review posts product approval summaries for the week ending 8/3/2018.
Federal Register notice: CDER announces the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Progra...
Federal Register notice: FDA determines that Plasma Lyte M And Dextrose 5% and Plasma Lyte and Dextrose 5% were not withdrawn for reasons of safety o...
Federal Register notice: FDA makes available a draft guidance entitled Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebo...
The U.S. Court of Appeals for the Seventh Circuit reverses a lower court decision and $3 million verdict in a product liability that attempted to hold...