FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.
The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as drugs is flawed.
FDA launches a new Web page to highlight CDER Office of New Drugs regulatory science research activities.
Federal Register notice: FDA withdraws approval of a Merck NDA for arthritis drug Vioxx (rofecoxib).
An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.
CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.
Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico.
CDER Office of Compliance director Don Ashley tells a regulatory conference that the Center is planning a guidance document on the modernization of cl...