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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, […]
April 8, 2020

Genesis 2 Church – 606459 – 04/08/2020

Product: Drugs Date:            April 8, 2020 RE:               Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United […]
April 8, 2020

CPG Sec. 480.100 Requirements for Expiration Dating and Stability Testing

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research BACKGROUND: Revisions to 21 CFR Part 211, Current Good […]
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