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April 27, 2020

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry

Docket Number: FDA-2012-D-0880 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug […]
April 27, 2020

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017

Docket Number: FDA-2012-D-0880 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug […]
April 27, 2020

Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

Docket Number: FDA-2001-D-0506 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist […]
April 27, 2020

Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report

Docket Number: FDA-1997-D-0445 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The FDA has undertaken a major […]
April 27, 2020

Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

Docket Number: FDA-2007-D-0434 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides guidance to industry on postmarketing serious adverse event reporting […]
April 27, 2020

Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling

Docket Number: FDA-2004-D-0459 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes a basic framework for designing and conducting PK/PD studies […]
April 27, 2020

Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling

Docket Number: FDA-2010-D-0133 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist sponsors planning to conduct studies to […]
April 27, 2020

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

Docket Number: FDA-1999-D-0063 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides recommendations to sponsors […]
April 27, 2020

Pharmacogenomic Data Submissions

Docket Number: FDA-2003-D-0031 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Biologics Evaluation and Research […]
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