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Federal Register notice: FDA makes available a draft guidance entitled Computer Software Assurance for Production and Quality Syst...[ Price : $8.95]
FDA publishes a final rule setting a new deadline for the annual summary report required under the Right to Try Law.[ Price : $8.95]
The International Society for Cell & Gene Therapy says a federal court decision that FDA cannot regulate cell therapy products as ...[ Price : $8.95]
FDA launches a new Web page to highlight CDER Office of New Drugs regulatory science research activities.[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Merck NDA for arthritis drug Vioxx (rofecoxib).[ Price : $8.95]
An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.[ Price : $8.95]
CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.[ Price : $8.95]
Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico....