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May 6, 2020

Transdermal and Topical Delivery Systems – Product Development and Quality Considerations

Docket Number: FDA-2019-D-4447 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides recommendations to applicants and manufacturers of transdermal and topical […]
May 6, 2020

Time and Extent Applications for Nonprescription Drug Products

Docket Number: FDA-2004-D-0438 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to explain what information an applicant should submit […]
May 6, 2020

Third of a series of letters regarding the implementation of the Act

Docket Number: FDA-2011-D-0595 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This is the third in a series of letters intended to inform […]
May 6, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 5, 2020

For Immediate Release: May 05, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 5, 2020

FDA approves new treatment for a type of heart failure

For Immediate Release: May 05, 2020 Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection […]
May 5, 2020

Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format

Docket Number: FDA-2011-D-0694 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]
May 5, 2020

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs

Docket Number: FDA-2018-D-3462 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food […]
May 5, 2020

User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR

Docket Number: FDA-2005-D-0083 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes the circumstances under which user fees will not be […]
May 5, 2020

Endocrinologic and Metabolic Drugs Advisory Committee Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
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