CDER Office of Prescription Drug Promotion senior social science research analyst Katherine Aikin explains the work her unit does on patient-level ind...
The CDER Office of Pharmaceutical Quality reports on its 2021 core function activities and efforts to carry out White House recommendations for improv...
Federal Register notice: FDA makes available a final guidance entitled Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints A...
AdvaMed comments on an FDA proposed information collection to prepare transition plans for some medical devices after the Covid-19 health emergency en...
FDA issues a second complete response letter in less than 18 months to Mallinckrodt for its NDA for terlipressin to treat adults with hepatorenal synd...
FDA releases a lengthy FDA-483 with 13 observations from a two-month inspection at Colchester, VT-based Edge Pharma drug outsourcing facility.
Sanofi and GlaxoSmithKline say a Phase 3 trial of their Covid-19 vaccine showed it was 100% effective against severe Covid disease and hospitalization...
AbbVie files a supplemental NDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder in patients who are receiving ongo...