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FDA publishes for comment the International Council for Harmonization M14 guidance on general principles for planning, designing, ...[ Price : $8.95]
FDA accepts for priority review a Sanofi supplemental BLA for Sarclisa (isatuximab) in combination with standard of care for treat...[ Price : $8.95]
FDA co-sponsors a 6/26-27 public workshop on using patient-generated health data in medical device development.[ Price : $8.95]
FDA publishes a draft guidance on the drug development platform technology designation program.[ Price : $8.95]
Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file r...[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the crite...[ Price : $8.95]
Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 201...[ Price : $8.95]
Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending...