Two Florida men are charged as part of an Insys Subsys kickback and bribery scheme.
FDA dietary supplements director Steven Tave tells an industry conference about a regulatory gap between what the law requires and what enforcement ca...
FDA accepts for priority review a CytRx NDA for arimoclomol for treating Niemann-Pick disease Type C.
A Washington Post opinion piece takes issue with President Trump and his administrations meddling for political purposes in FDA and CDC activities rel...
FDA encourages stakeholders who are developing drugs containing cannabis to consider using the drug master file pathway to protect proprietary informa...
Federal Register notice: FDA issues a priority review voucher to AstraZeneca for an approved rare pediatric disease product Koselugo (selumetinib).
Federal Register notice: FDA makes available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biological Product Labelin...
Attorney Sara Koblitz says Californias governor is considering signing legislation that would make the state a partner in drug manufacturing and distr...