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April 21, 2020

ANDA Submissions — Content and Format of Abbreviated New Drug Applications

Docket Number: FDA-2014-D-0725 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 21, 2020

ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA

Docket Number: FDA-2017-D-5670 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to explain […]
April 21, 2020

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

Docket Number: FDA-2018-D-4726 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
April 21, 2020

Analytical Procedures and Methods Validation for Drugs and Biologics

Docket Number: FDA-2015-N-0007 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 21, 2020

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry

Docket Number: FDA-2013-N-0035 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The purpose of this guidance is […]
April 21, 2020

Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy

Docket Number: FDA-2013-D-0077 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The purpose of this guidance is […]
April 21, 2020

Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs

Docket Number: None found Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to […]
April 21, 2020

Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry

Docket Number: FDA-2000-D-0277 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The purpose of this guidance is […]
April 21, 2020

Alcoholism: Developing Drugs for Treatment

Docket Number: FDA-2015-D-0152 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The purpose of this guidance is […]
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