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February 1, 2021

Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997

Docket Number: FDA-1999-N-0098 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is […]
February 1, 2021

Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 – Specific Electronic Submissions Intended For FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed […]
February 1, 2021

(Potassium Iodide) KI in Radiation Emergencies-Questions and Answers

Docket Number: None found Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides answers to questions that FDA has received as […]
February 1, 2021

Abuse-Deterrent Opioids-Evaluation and Labeling

Docket Number: FDA-2013-D-0045 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance explains FDA’s current thinking about the studies that should be […]
February 1, 2021

Carcinogenicity Study Protocol Submissions

Docket Number: FDA-2000-D-1405 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to inform sponsors of the types of information […]
February 1, 2021

Role of HIV Drug Resistance Testing in Antiretroviral Drug Development

Docket Number: FDA-2004-D-0242 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors in the clinical development of […]
February 1, 2021

Influenza: Developing Drugs for Treatment and/or Prophylaxis

Docket Number: FDA-2009-D-0044 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the development […]
February 1, 2021

Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance discusses how FDA plans to exercise its enforcement discretion after August 14, 2001, […]
January 29, 2021

Coronavirus (COVID-19) Update: January 29, 2021

For Immediate Release: January 29, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
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