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Federal Register notice: FDA makes available a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Presc...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