fbpx
May 15, 2020

PET Drug Applications – Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011

Docket Number: FDA-2000-D-1542 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Date: August 2011 These sample formats for the chemistry, manufacturing, and controls […]
May 15, 2020

Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans

Docket Number: FDA-2013-D-0814 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to provide information to sponsors regarding […]
May 15, 2020

Pediatric Rare Diseases–A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry

Docket Number: FDA-2017-N-6476 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The emergence of concomitant trials for multiple investigational drug products for the […]
May 15, 2020

Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice

Docket Number: FDA-2013-D-0169 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance is intended to assist […]
May 15, 2020

Pediatric HIV Infection: Drug Development for Treatment

Docket Number: FDA-2018-D-1638 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is […]
May 15, 2020

Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry

Docket Number: FDA-2017-D-5912 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in the clinical […]
May 14, 2020

Internal Radioactive Contamination —Development of Decorporation Agents

Docket Number: FDA-2005-D-0025 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides guidance to industry on the development of decorporation agents […]
May 14, 2020

Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry

Docket Number: FDA-2017-D-2165 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The purpose of this guidance is to assist sponsors in evaluating reproductive […]
May 14, 2020

Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data

Docket Number: FDA-2015-D-4021 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance addresses the current thinking of the Food and Drug Administration’s […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0