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April 29, 2020

Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

Docket Number: FDA-1999-D-0050 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is announcing the availability of a […]
April 29, 2020

Bioanalytical Method Validation Guidance for Industry

Docket Number: FDA-2013-D-1020 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Veterinary Medicine The Food and Drug Administration (FDA or Agency) […]
April 29, 2020

Best Practices in Developing Proprietary Names for Drugs

Docket Number: FDA-2014-D-0622 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA is issuing this guidance to help sponsors of human drugs, including […]
April 29, 2020

Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets

Docket Number: FDA-2011-D-0057 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes best practices pertaining […]
April 29, 2020

Best Practices for Communication Between IND Sponsors and FDA During Drug Development

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written […]
April 28, 2020

Coronavirus (COVID-19) Update: Daily Roundup April 28, 2020

For Immediate Release: April 28, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
April 28, 2020

DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers

Docket Number: FDA-2014-D-2083 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Comments and suggestions regarding this draft document should be submitted within 60 […]
April 28, 2020

Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry

Docket Number: FDA-2014-D-0609 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of Regulatory Affairs This guidance […]
April 28, 2020

Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry

Docket Number: FDA-2019-D-4247 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft guidance describes how we […]
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