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April 24, 2020

M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers

Docket Number: FDA-2008-D-0470 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

M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Docket Number: FDA-2008-D-0470 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

Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products

Docket Number: FDA-2012-D-1135 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research    U.S. Department of Health and […]
April 24, 2020

Levothyroxine Sodium Tablets – In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing

Docket Number: FDA-1999-D-0010 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

Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act

Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. […]
April 24, 2020

Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs

Docket Number: FDA-2001-D-0135 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 for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

Docket Number: FDA-2005-D-0153 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 Biosimilar Products Guidance for Industry

Docket Number: FDA-2016-D-0643 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

IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects

Docket Number: FDA-2017-D-3235 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Office of Clinical Policy, Office of Good Clinical Practice Office of Medical […]
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