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May 4, 2020

Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation — Small Entity Compliance Guide

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This small entity compliance guide is one of a series of guidance documents prepared in […]
May 4, 2020

Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice

Docket Number: FDA-2003-D-0145 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance […]
May 4, 2020

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry

Docket Number: FDA-2018-D-0481 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This draft guidance describes the electronic […]
May 4, 2020

Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Guidance for Industry

Docket Number: FDA-2013-D-1170 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 4, 2020

Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment

Docket Number: FDA-2018-D-3903 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
May 4, 2020

Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry

Docket Number: FDA-2018-D-0688 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]
May 4, 2020

Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment

Docket Number: FDA-2000-D-0037 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to provide recommendations to sponsors for […]
May 4, 2020

SPL Standard for Content of Labeling Technical Qs & As

Docket Number: FDA-2009-D-0355 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is intended to assist […]
May 4, 2020

Charging for Investigational Drugs Under an IND – Questions and Answers

Docket Number: FDA-2013-D-0447 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides information for industry, […]
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