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May 14, 2020

Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry

Docket Number: FDA-2019-D-1516 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 14, 2020

New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products

Docket Number: FDA-2008-D-0525 Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products Center for Drug Evaluation […]
May 14, 2020

New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products

Docket Number: FDA-2013-D-1675 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or the Agency) is issuing this […]
May 14, 2020

Human Drug Exports

FDA works to promote and protect the public health by promoting supply chain integrity of human drug exports. Companies exporting drugs from the U.S. as well […]
May 14, 2020

Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996

Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and […]
May 14, 2020

Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention

Docket Number: FDA-2011-D-0587 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the development […]
May 13, 2020

FDA-ASCO PUBLIC WORKSHOP: 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop – 07/17/2020 – 07/17/2020

On This Page Date: July 17, 2020 Time: 9:00 AM – 4:00 PM ET Twitter: #OCEOutcomes20  Co-Sponsor: American Society of Clinical Oncology (ASCO) Co-Chairs: U.S. Food […]
May 13, 2020

Office of Infectious Diseases Research Activities

Antimicrobial Regulatory Science Research Antibacterial drug resistance is a major threat to public health.  In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]
May 13, 2020

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference – 06/04/2020 – 06/05/2020

Meeting Overview The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on […]
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