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FDA
US Continues to Face Drug Shortages
Once again we are facing national shortage of key drugs, including anesthetics, painkillers, antibiotics, and cancer…
BioSimilars: FDA Panel Overwhelming Recommends Approval of Remicade…
Yesterday an FDA Advisory panel overwhelmingly recommended the Celltrion/Pfizer biosimilar Remsima 21-3 for approval for…
An Update on the Nomination of FDA Commissioner Robert Califf
An increasing number of senators are threatening to block Dr. Robert Califf's nomination to be the next Commissioner of…
FDA CDER Update 2016
We recently reported that 2015 resulted in the highest level of newly approved U.S. drugs in nineteen years. This…
FDA Fixed Combination and Co-packaging Proposed Rule
Earlier this year the FDA announced its intention to issue a rule on fixed-dose combinations and co-packaged products. On…
Health and Human Services Regulatory Agenda for 2016
The Department of Health and Human Services recently released their semi-annual regulatory agenda, a listing of rules…
A Year in Review: FDA 2015 New Drug Approvals
The approval of first-of-a-kind drugs rose last year to forty-one, resulting in the highest level of newly approved U.S.…
Pacira Settlement and the Future
Pacira Pharmaceuticals announced a settlement with the United States Food and Drug Administration (FDA) in connection…
FDA DSCSA Implementation: Product Tracing Requirements for Dispensers –…
The Drug Supply Chain Security Act (DSCSA) requires most of the entities along the drug supply chain--from manufacturers…
FDA: Review of Advisory Committees 2008-2012, Fewer Meetings and More…
Over the years, we have written about the FDA's Advisory Committees with a special interest on "conflict of interest"…