Attorney Sara Koblitz says the generic drug industry has been upended by a Federal Circuit Court of Appeals ruling that Teva induced infringement of a...
FDA releases the FDA-483 with 10 observations from an inspection at Japans Toyobo Co.
FDA approves Impel NeuroPharmas Trudhesa migraine nasal spray treatment.
FDA approves a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death.
FDA Revire posts the Federal Register notices for the week ending 9/3/2021.
FDA review posts product approval summaries for the week ending 9/3/2021.
Federal Register notice: FDA renews its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expir...
FDA cautions that it may only be able to give the green light for booster shots later this month to those vaccinated with the Pfizer/BioNTech Covid-19...