The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
The U.S. Food and Drug Administration is seeking to accelerate the review process for three companies that are studying psilocybin and an MDMA-like drug as treatments for depression and PTSD ...
The FDA rejected the promising skin cancer drug RP1 twice, leaving many puzzled and worried about what this means for other drug approvals ...
Health and Human Services Secretary Robert F. Kennedy Jr. unveiled a new plan on Wednesday that he said will drastically reduce drug prices in the U.S. He said the U.S. Food and Drug Administration is ...
A new draft guidance document released by the US Food and Drug Administration (FDA) on 24 July 2013 concerns so-called Pre-Launch Activities Importation Requests (PLAIRs), requests to FDA to allow the ...
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