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April 9, 2020

Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
April 9, 2020

Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry

Docket Number: FDA-2019-D-5270 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 8, 2020

Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers

Docket Number: FDA-1992-N-0056 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Prescription Drug Marketing Act of […]
April 8, 2020

Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics

Docket Number: FDA-2002-D-0092 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides information for free […]
April 8, 2020

Premarketing Risk Assessment

Docket Number: FDA-2004-D-0121 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 8, 2020

Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Sponsors are encouraged to use the following sample format […]
April 8, 2020

Q4B Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter

Docket Number: FDA-2008-D-0081 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 8, 2020

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Annex 13: Bulk Density and Tapped Density of Powders General Chapter

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]
April 8, 2020

Q4B Annex 10: Polyacrylamide Gel Electrophoresis General Chapter

Docket Number: FDA-2009-D-0342 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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