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April 29, 2020

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

Docket Number: FDA-2018-D-0719 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Good Clinical Practice (GCP) is an […]
April 29, 2020

E5 Ethnic Factors in the Acceptability of Foreign Clinical Data

Docket Number: FDA-1997-D-0360 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is publishing a guidance entitled ‘‘E5 […]
April 29, 2020

E4 Dose-Response Information to Support Drug Registration

Docket Number: FDA-1993-D-0183 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Knowledge of the relationships among dose, drug concentration drug concentration in blood, […]
April 29, 2020

E3 Structure and Content of Clinical Study Reports – Questions and Answers (R1)

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Since the ICH E3 guidance was made final, experiences […]
April 29, 2020

E3 Structure and Content of Clinical Study Reports

Docket Number: FDA-1995-D-0201 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The objective of this guideline is to facilitate the compilation of a […]
April 29, 2020

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

Docket Number: FDA-1993-D-0128 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research It is important to harmonize the way to gather and, if necessary, to […]
April 29, 2020

E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions

Docket Number: FDA-1994-D-0267 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The objective of this guideline is to present an accepted set of […]
April 29, 2020

E18 Genomic Sampling and Management of Genomic Data Guidance for Industry

Docket Number: FDA-2016-D-1255 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research […]
April 29, 2020

Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations

Docket Number: FDA-2014-D-0204 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA) is announcing the availability of a […]
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