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Federal Register notice: FDA seeks comments on an information collection extension entitled Prescription Drug Product Labeling; Me...[ Price : $8.95]
Faced with resistance from the pharmaceutical industry, Health and Human Services Secretary and former Eli Lilly executive Alex Az...[ Price : $8.95]
Three Hyman, Phelps attorneys argue that CDER should change its current process and permit applicants who receive a complete respo...[ Price : $8.95]
FDA publishes a draft ICH guidance on biopharmaceutics classification system-based biowaivers.[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Testicular Toxicity: Evaluation During Drug Development.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Verification Systems Under the Drug Supply Chain Security A...[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency gained new authorities under the SUPPORT bill to combat the nations opioid crisis....[ Price : $8.95]
CDRH posts information about its planned Accreditation Scheme for Conformity Assessment pilot program to accredit testing laborato...