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April 15, 2020

Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

Docket Number: FDA-2013-D-1165 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 15, 2020

Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions

Docket Number: FDA-2014-D-1862 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research FDA is informing manufacturers, members of […]
April 15, 2020

Drug Trials Snapshots: KOSELUGO

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
April 15, 2020

Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry

Docket Number: FDA-2012-D-0529 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance applies to single-ingredient aspirin, […]
April 15, 2020

Rare Pediatric Disease Priority Review Vouchers

Docket Number: FDA-2014-D-1461 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Office of Clinical Policy, Office of Orphan Products Development Office of Medical […]
April 15, 2020

Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry

Docket Number: FDA-2011-D-0611 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
April 15, 2020

Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry

Docket Number: FDA-2015-D-2843 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides a qualified context […]
April 15, 2020

Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry

Docket Number: FDA-2015-D-2244 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Contains Nonbinding Recommendations Submit Comments You […]
April 15, 2020

Remarks by Dr. Hahn to the 2020 Rx Drug Abuse and Heroin Summit – 04/15/2020

(Remarks as prepared for delivery) I want to extend my warmest greetings to all of you who are participating in this year’s virtual Rx Drug Abuse […]
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