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Forbes commentator Bernard Munos says drug companies should fix their own problems with drug innovation rather than blaming FDA.[ Price : $8.95]
Former FDAer Scott Gottlieb and Sen. Tom Coburn call on FDA to quickly reject generic opioids that are not tamper-resistant.[ Price : $8.95]
Amarin asks FDA to approve Chemport as an additional API supplier for its Vascepa.[ Price : $8.95]
FDA accepts Roches MycoTOOL as the first commercially available mycoplasma test for release testing of a biopharmaceutical product...[ Price : $8.95]
ViroPharma Inc. initiates a Phase 2b study to evaluate the safety and efficacy of subcutaneous Cinryze in combination with Halozym...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, Providing Submissions in Electronic Format Summary Level Clinical Site Da...[ Price : $8.95]
FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula ophthalmic solution to allow its use as a first-line therapeut...[ Price : $8.95]
Matrixx Initiatives recalls one lot of Zicam Extreme Congestion Relief nasal gel after finding a small amount of Burkholderia cepa...