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.
Pfenex files a 505(b)(2) NDA for PF708, referencing Eli Lillys osteoporosis drug Forteo.
FDA clears a Pear Therapeutics 510(k) for its mobile medical application to help increase retention in an outpatient treatment program for individuals...
FDA posts a revised draft guidance entitled Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Sect...