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Federal Register notice: FDA seeks comments on an information collection revision entitled Administrative Procedures for Clinical ...[ Price : $8.95]
FDA says its Psychopharmacologic Drugs Advisory Committee will consider whether data from Acadia Pharmaceutical trials support an ...[ Price : $8.95]
Four Alston & Bird attorneys describe some of the major items in the PDUFA 7 reauthorization legislation that has bipartisan suppo...[ Price : $8.95]
Pfizer says it will stop enrolling standard risk patients in the EPIC-SR trial of its anti-Covid therapy Paxlovid and submit data ...[ Price : $8.95]
The Senate Health, Education, Labor and Pensions Committee passes the FDA Safety and Landmark Advancements (FDASLA) Act, which rea...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance for industry entitled Q9(R1) Quality Risk Management (QRM).[ Price : $8.95]
CDER director Patrizia Cavazzoni tells FDLI she is personally spearheading the Centers new rare disease efforts to speed and incre...[ Price : $8.95]
FDA publishes a draft guidance on the voluntary consensus standards recognition program for regenerative medicine therapies.