Shire files a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin 25% [albumin (human...
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Eli Lillys Taltz (ixekizumab).
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Federal Register notice: FDA makes available a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Presc...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.