Tag: NASH

Jan-March 2021 CDER Meetings and Conferences

January Jan. 14 CDER Compliance Conference Jan. 26 Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling Jan. 27 OTC Monograph Reform in the CARES Act: Safety Orders, Webinar Jan. 27 Public Meeting: Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act Jan. 29 Regulatory Perspectives for Development of Drugs […]

FREE Webinar: Regulatory Perspectives for Development of Drugs for Treatment of NASH

The following FDA webinar is FREE and offers SOCRA CE! Regulatory Perspectives for Development of Drugs for Treatment of NASH January 29, 2021 | 1:00 – 2:30 PM Eastern Register here: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-perspectives-development-drugs-treatment-nash-01292021-01292021?utm_medium=email&utm_source=govdelivery FDA will provide a summary of FDA’s current thinking on the published draft guidance documents: Non-cirrhotic Non-alcoholic Steatohepatitis (NASH): Developing Drugs for Treatment, and Non-alcoholic Steatohepatitis […]

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