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April 14, 2020

Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability

Docket Number: FDA-1997-D-0098 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Product Recalls, Including Removals and Corrections

Submit Comments by 04/02/2021 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
April 14, 2020

Q2B Validation of Analytical Procedures: Methodology

Docket Number: FDA-1996-D-0169 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Q2A Text on Validation of Analytical Procedures

Docket Number: FDA-1994-D-0401 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Providing Submissions in Electronic Format — Postmarketing Safety Reports

Docket Number: FDA-2001-D-0067 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers

Docket Number: FDA-2013-D-0755 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Providing Regulatory Submissions in Electronic Format –Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling

Docket Number: FDA-2017-E-4282 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

Docket Number: FDA-2014-D-1953 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 14, 2020

Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs

Docket Number: FDA-2015-D-1163 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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