FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, and analyzing pharma...
FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treating patients with tr...
FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.
FDA publishes a draft guidance on the drug development platform technology designation program.
Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file required annual repor...
Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the criteria for a material t...
Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 2019 opinion blocking F...
Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...
