FDA Related News

Human Drugs

4 New Biosimilar Guidances

FDA commissioner Scott Gottlieb outlines provisions in four guidances to help advance the agencys Biosimilars Action Plan.

HHS Sued Over Trial Reporting Rule

Former FDAer Peter Lurie and journalism professor Charles Seife sue HHS, FDA, and NIH to overturn a final rule allowing some drug and medical device c...

Human Drugs

Biomarker Qualification Draft Guidance

FDA issues a draft guidance on the evidentiary framework it recommends for biomarker qualification under the 21st Century Cures Act.

Human Drugs

Amino Acid Polymer Product Assessment

CDER issues a MAPP on procedures for integrated quality assessment of products containing drug substances composed of amino acid polymers.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Skylark CMC and Zhejiang Huahai Pharmaceutical.

Human Drugs

Dishman Carbogen FDA-483

FDA released an FDA-483 with two observations issued to Dishman Carbogen Amcis in Gujarat, India.

Medical Devices

Stakeholders Urge Congress to Axe the Device Tax

More than 140 industry and advocacy groups urge Congress to permanently repeal the medical device tax before the end of this year.

Human Drugs

CMC Human Gene Therapy Guidance Inadequate: PhRMA

Stakeholders say a draft FDA guidance on CMC information for human gene therapy needs to be clarified and reorganized.

Human Drugs

Revised Draft Guide on Outsourcing Facility GMPs

FDA posts a revised draft guidance entitled Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Sect...

Federal Register

Panel to Discuss Vaginal Surgical Mesh

Federal Register notice: FDA announces a 2/12 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting to discuss vag...