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April 24, 2020

IRB Continuing Review After Clinical Investigation Approval

Docket Number: FDA-2009-D-0605 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Office of Clinical Policy, Office of Good Clinical Practice Office of Medical […]
April 24, 2020

Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

Docket Number: FDA-2014-D-0397 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
April 24, 2020

Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules

Docket Number: FDA-2013-N-1434 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Tablets and capsules are widely manufactured […]
April 24, 2020

Size of Beads in Drug Products Labeled for Sprinkle Rev.1

Docket Number: FDA-2011-D-0021 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides applicants preparing or […]
April 24, 2020

Single Dose Acute Toxicity Testing for Pharmaceuticals

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 24, 2020

Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 24, 2020

Labeling OTC Human Drug Products; Small Entity Compliance Guide

Docket Number: FDA-2004-D-0122 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA) […]
April 24, 2020

Labeling OTC Human Drug Products — Questions and Answers

Docket Number: FDA-2004-D-0437 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to assist […]
April 24, 2020

Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers

Docket Number: FDA-2007-D-0429 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This document is intended to assist […]
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