Fda compliance program guidance manual chapter 48

compliance program guidance manual program date of issuance: 3/11/ cover - page 1 of 1 form fda g (electronic/) chapter 48 – bioresearch monitoring. subject: sponsors, contract research organizations and monitors. implementation date. ma. F OOD A ND D RUG A DMINISTRATION C OMPLIANCE P ROGRAM G UIDANCE M ANUAL PROGRAM Chapter 48 - Bioresearch Monitoring Date of Issuance: PAGE 1 02/23/01 FORM FDA j Implementation Date Febru Subject SPONSORS, CONTRACT RESEARCH. Date of Issuance: 07/22/ Page 1 of 64 FORM FDA g (electronic /) FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM CHAPTER .

Date of Issuance: 07/22/ Page 1 of 64 FORM FDA g (electronic /) FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM CHAPTER BIORESEARCH MONITORING. FDA drug regulations do not explicitly address protocol deviations. However, the issue is directly addressed in the FDA “Compliance Program Guidance Manual, Program , Chapter 48 – Bioresearch Monitoring, Clinical Investigators and Sponsor-Investigators, December 8, ” The manual states: Protocol deviations. Compliance Program Manual. FDA’s Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act.

Compliance Programs (program plans and instructions) directed to field the requirements of the applicable statutes and regulations. FDA Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) Internet. 8 dic CHAPTER BIORESEARCH MONITORING To assess compliance with FDA's regulations governing the conduct of clinical trials.