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April 24, 2020

Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Docket Number: FDA-2014-D-0250 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 24, 2020

Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information

Docket Number: FDA-2007-D-0302 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 24, 2020

Labeling for Combined Hormonal Contraceptives Guidance for Industry

Docket Number: FDA-2017-D-1846 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations on information […]
April 24, 2020

Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide)

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research  (Small Entity Compliance Guide) U.S. Department of Health and […]
April 24, 2020

Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research U.S. Department of Health and Human ServicesFood and Drug […]
April 24, 2020

Label Comprehension Studies for Nonprescription Drug Products

Docket Number: FDA-2009-D-0181 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

Irritable Bowel Syndrome — Clinical Evaluation of Products for Treatment

Docket Number: FDA-2010-D-0146 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

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Office of Clinical Policy, Office of Good Clinical Practice Office of Medical Products and Tobacco, […]
April 24, 2020

Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs

Docket Number: FDA-2012-D-0081 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance summarizes the investigational new […]
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