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May 22, 2024This would produce approval of ambroxol as over-the-counter medication for coughs and colds without unnecessary new clinical trials. And should�...
The Left on FDA Peer Approval. by Alex Tabarrok May 22, 2024 at 7:20 ... To get FDA approval for the sale of ambroxol in the U.S., a�...
Jun 14, 2024Many countries look to the US FDA for guidance on approval decisions. In fact the FDA will sometimes receive and evaluate drugs and vaccines�...
Aug 26, 2015I have long argued that the FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more�...
Dec 4, 2023Given that FDA predicts 50 percent of tests would require premarket review, and 5 percent will require premarket approval, we have serious�...
... FDA recognizes the Canadian Food Inspection Agency as a peer. Peer approval means that food imports from and exports to Canada can be sped through�...
May 28, 2024Peer approval means that food imports from and exports to Canada can be sped through regulatory paperwork, bringing benefits to both Canadians�...
Oct 1, 2011Why do we need another NSAID? It was approved precisely because it was supposed to be safer than the others on the market. Even under Grove's�...
May 31, 2024Influenced by my work on FDA reciprocity aka peer approval, Ted Cruz introduced a bill, the Result Act to fast-track approval in the United�...
Jul 5, 2024... FDA rule that gives the agency more oversight of lab-developed tests, lengthening the pathway to approval ... peer approval, Trefethen gets�...