Attorney Amanda Johnston explains five steps FDA-regulated company executives can take to mitigate the risk of Park Doctrine violations.
FDA approves an expanded ventricular tachycardia indication for Abbotts FlexAbility catheter.
FDA publishes the International Council on Harmonization M13A guidance on bioequivalence for immediate-release solid oral dosage forms.
FDA says two Covid-19 therapeutics can now be prescribed without having a positive test result showing Covid-19 infection when a physician suspects su...
Federal Register notice: FDA announces a 2/28 to 3/1 Vaccines and Related Biological Products Advisory Committee meeting to discuss two BLAs for respi...
CDER says Lexicon has failed to justify its request for an agency hearing on the Centers refusal to approve the companys NDA for sotagliflozin to help...
CDER releases its proposed 2023 guidance agenda showing 98 planned new and revised guidances in 18 categories.
FDA publishes a draft guidance with recommendations about developing drugs for treating early Lyme disease as manifested by erythema migrans.
