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April 22, 2020

ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

Docket Number: FDA-2014-D-0547 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides answers to questions […]
April 22, 2020

ANDAs: Impurities in Drug Substances

Docket Number: FDA-1998-D-0021 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides revised recommendations on […]
April 22, 2020

ANDAs: Impurities in Drug Products

Docket Number: FDA-2010-D-0584 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations on what […]
April 22, 2020

Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act

Docket Number: FDA-2014-D-0829 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 22, 2020

How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

Docket Number: FDA-2014-D-1891 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance describes how a prospective […]
April 21, 2020

ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers Guidance for Industry

Docket Number: FDA-2017-D-5846 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This draft guidance is intended to […]
April 21, 2020

ANDA Submissions — Refuse-to-Receive Standards Rev.2

Docket Number: FDA-2013-D-1120 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to assist […]
April 21, 2020

ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits

Docket Number: FDA-2014-D-1292 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to assist […]
April 21, 2020

ANDA Submissions – Prior Approval Supplements Under GDUFA

Docket Number: FDA-2014-D-0901 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to assist […]
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