FDA commissioner Scott Gottlieb outlines provisions in four guidances to help advance the agencys Biosimilars Action Plan.
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...
FDA issues a draft guidance on the evidentiary framework it recommends for biomarker qualification under the 21st Century Cures Act.
CDER issues a MAPP on procedures for integrated quality assessment of products containing drug substances composed of amino acid polymers.
FDA releases its latest batch of Warning Letters that include Skylark CMC and Zhejiang Huahai Pharmaceutical.
FDA released an FDA-483 with two observations issued to Dishman Carbogen Amcis in Gujarat, India.
More than 140 industry and advocacy groups urge Congress to permanently repeal the medical device tax before the end of this year.
Stakeholders say a draft FDA guidance on CMC information for human gene therapy needs to be clarified and reorganized.