Pharmacometrics: The science applied from bench to bedside

Bhavatharini P A,Arun K P,Deepalakshmi M

doi:10.7324/japs.2021.120104

Abstract

Phytochemical screening and Antimicrobial activity of the leaves of Memecylon umbellatum burm. F.Subban Murugesan, Annamalai Pannerselvam, Arumugame Chanemougame Tangavelou

Highlights

The guidance does not describe: (1) standards for approval of drug and biological products in the pediatric population, (2) criteria to allow a determination that the course of a disease and the effects of a drug or a biologic are the same in adults and pediatric populations, or (3) clinical pharmacology studies for vaccine therapy, blood products, or other products not. This draft guidance has been prepared by the Pediatric Working Group of the Office of Clinical Pharmacology in conjunction with the Pediatric Subcommittee of the Medical Policy Coordinating Committee (MPCC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration
2 For purposes of this guidance, references to "drugs" and "drug and biological products" includes drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products licensed under 351 of the Public Health Service Act (PHSA) (42 U.S.C. 262) that are drugs
Sponsors must submit a request for a deferral or waiver as part of an initial pediatric study plan (section 505B(e) of the FD&C Act). 68 The FD&C Act requires a description of pediatric study data in labeling arising from study data

Summary

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document, contact (CDER) Gilbert J. Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration

Contains Nonbinding Recommendations

Findings

Additional Factors