Four Republican senators call on FDA to expand its HIV/AIDS parallel track to other major diseases to speed drugs to patients.
Integra LifeSciences recalls its LimiTorr and MoniTorr Drainage Systems due to serious breakage and leakage complaints.
Federal Register notice: FDA submits to OMB an information collection extension entitled FDA Adverse Event Reports; Electronic Submissions 21 CFR 310...
Five stakeholders suggest changes to an FDA draft guidance on natural history studies on rare disease drug development.
FDA warns AMMD Labs about CGMP and other violations in its production and marketing of finished pharmaceuticals.
Pharm D Solutions recalls all sterile compounded drug products due to FDA inspection concerns that practices at the pharmacy have the potential to pos...
FDA places a clinical hold on Newron Pharmaceuticals proposed Phase 2-3 pivotal studies with evenamide for treating schizophrenia due to agency concer...
Federal Register notice: FDA extends the comment period on a draft guidance entitled Review and Update of Device Establishment Inspection Processes an...