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Federal Register

Info Collection on Compounding Outsourcing Facilities

Federal Register notice: FDA sends to OMB an information collection extension entitled Obtaining Information to Understand Challenges and Opportunitie...

Human Drugs

3 Groups Sue to Block Drug Import Rule

Three healthcare groups sue the Trump administration to block an HHS/FDA final rule that would permit some drug importation from Canada.

Human Drugs

CGMP Issues at AuroLife Pharma New Jersey Facilities

FDA warns AuroLife Pharma about CGMP violations at two of its New Jersey drug manufacturing facilities.

Human Drugs

Final Guide on Drug Development Tools

FDA posts a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.

Human Drugs

Alnylam Pharma NDA for Oxlumo Approved

FDA approves an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), a rare genetic disor...

Human Drugs

ANDA Complex Product Meeting Guidance

FDA issues a guidance to assist ANDA applicants for complex products to schedule and conduct several types of meetings with agency staff.

Medical Devices

Panelists Review CDRH Digital Health Goals

CDRH holds a second listening session on its new Digital Health Center of Excellence and examines whether it is pursuing the most appropriate goals.

Human Drugs

Expiration Date Extended for 42 Cutaquig Lots

FDA extends from 24 to 36 months the expiration date for 42 lots of Cutaquig if they are stored at a cooler temperature.

Medical Devices

Neuronetics TouchStar Protocol Cleared for Depression

FDA clears a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its NeuroStar Advanced Ther...

Medical Devices

FDA Recognizes ANSI Accreditation Board for ASCA Pilot

FDA recognizes the ANSI board as an accreditation body for the agencys Accreditation Scheme for Conformity Assessment pilot project.