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April 30, 2020

Changes to an Approved NDA or ANDA

Docket Number: FDA-1999-D-0049 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to holders of new drug applications (NDAs) and […]
April 30, 2020

Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products

Docket Number: FDA-1995-D-0101 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance applies only to specified […]
April 30, 2020

Cancer Drug and Biological Products – Clinical Data in Marketing Applications

Docket Number: FDA-2000-D-0100 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This document provides recommendations for sponsors […]
April 30, 2020

Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application

Docket Number: None found Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist manufacturers wishing to submit new […]
April 30, 2020

Bridging for Drug-Device and Biologic-Device Combination Products

Docket Number: FDA-2019-D-5585 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]
April 29, 2020

Coronavirus (COVID-19) Update: Daily Roundup April 29, 2020

For Immediate Release: April 29, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
April 29, 2020

Elemental Impurities in Drug Products Guidance for Industry

Docket Number: FDA-2016-D-1692 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations regarding the […]
April 29, 2020

Electronic Submission of Lot Distribution Reports

Docket Number: FDA-2014-D-1288 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides you, licensed manufacturers […]
April 29, 2020

Electronic Submission of IND Safety Reports Technical Conformance Guide

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this […]
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