The Justice Department says five individuals and two companies are pleading guilty to fraudulently marketing two workout and weight loss dietary suppl...
A New York federal judge says a whistleblower suit against a Teva speakers program for two drugs may proceed to trial.
Healthcare communications consultant Mark Senak says the CDER Office of Prescription Drug Promotion is showing an enforcement focus on promotion of un...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients....
FDA releases the FDA-483 with 10 observations from an inspection at the Genetech umbilical cord processing facility.
FDA grants Purdue Pharma a fast track designation for nalmefene hydrochloride injection, an investigational opioid antagonist for the emergency treatm...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
Federal Register notice: FDA makes available a final guidance entitled Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clini...