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FDA issues two final guidances explaining its views on making benefit/risk determinations for certain medical device approval appl...[ Price : $8.95]
FDA issues an FDA-483 with eight observations from an inspection at Dr. Reddys drug manufacturing facility in Andhra, Pradesh, Ind...[ Price : $8.95]
FDA grants Emalex Biosciences a fast track designation for its investigational drug ecopipam for treating patients with Tourette S...[ Price : $8.95]
A CDER Office of Prescription Drug Promotion Webinar discusses contents of a recent guidance on providing promotional labeling and...[ Price : $8.95]
Federal Register notice: FDA extends the submission period related to a 6/29 notice on its drug Quality metrics feedback program.[ Price : $8.95]
Federal Register notice: FDA releases a final guidance on using placebos and allowing blinding in cancer clinical trials.[ Price : $8.95]
AstraZeneca says that the Phase 3 TULIP 2 trial for anifrolumab, an investigational drug for treating systemic lupus erythematosus...[ Price : $8.95]
Stakeholders praise and criticize an FDA draft guidance on a benefit/risk assessment framewok for opioids.