Category Archive: CBER

Nov 06 2019

New FDA Guidances for October 2019 and Upcoming Adcom Meetings

By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research Special Interest Guidances/Information Date Posted Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 01 November 2019 Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 01 November 2019 Electronic …

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