The House Energy and Commerce Committee asks for an FDA briefing on two opioid and fentanyl use and abuse issues.
FDA releases its latest batch of Warning Letters that includes International Hospital Products, Rxhomeo Private Ltd. and Xian Livingbond Nonwoven Prod...
FDA issues Daiichi Sankyo a complete response letter on its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid le...
FDA warns International Hospital Products about Quality System violations in its manufacturing of bowel decompression tubes.
Five stakeholders comment on an FDA draft guidance on initiating a voluntary regulated product recall.
FDA approves an Amag Pharmaceuticals NDA for Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal...
Federal Register notice: FDA submits to OMB an information collection extension entitled Reporting Associated With New Animal Drug Applications (NADA)...
Federal Register notice: FDA posts a final guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Lab...