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Federal Register notice: FDA releases two final guidances on drug interaction studies.[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application Sa...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled Draft Guidance for Levonorgestrel.[ Price : $8.95]
FDA posts a final guidance on Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Developme...[ Price : $8.95]
Federal Register notice: FDA announces a 2/26 Oncologic Drugs Advisory Committee meeting that will discuss a Steba Biotech NDA for...[ Price : $8.95]
FDA seeks outside groups or individual data scientists to develop computational algorithms to identify adverse event anomalies in ...[ Price : $8.95]
FDA grants accelerated approval for Epizymes Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older wit...[ Price : $8.95]
FDA approves an expanded indication for Abbotts Infinity Deep Brain Stimulation system to include targeting of an area of the brai...