# Presentation: 836512

## Introduction to Regulation

**Robert A. Yetter**
** ****Associate Director for Review Management**
**Center for Biologics Evaluation and Research**

## Contents

**History of FDA (short version)**
**FDA/CBER Structure **
**Regulatory Framework**
**Laws**
**Regulations**
**Guidance**
**Practical Advice**

## Short Legislative History

**Biologics Control Act (1902) (*****Biologics*****)**
**Began federal regulation of ***biologics*
**Food and Drugs Act (1906) (*****Food & Drugs*****)**
**Began federal regulation of ***drugs*
**FD&C Act amended (1938) (*****Food, Drugs, Devices, Cosmetics, ****Safety****)***
**PHS Act (1944) (*****Regulation of Biologics and Control of Communicable Diseases)***

## Short Legislative History

**FD&C amended (1962)(“Kefauver Amendments”) (***Efficacy****)***
**FD&C (1976) Medical Device Amendments**
**Established medical device regulations (previously devices regulated as drugs!)**
**FD&C amended (1990) Safe Medical Devices Act and (1992) Medical Device Amendments that fine tuned device law**

## Short Legislative History

**PDUFA (1992) Prescription Drug User Fee Act  (PDUFA I)**
**Allows fees to be charged for review**
**Reviews must be completed “on-time”**
**Timelines found in letter from HHS Secretary to Congress**
**Text of the June 4, 2002, letter transmitting the PDUFA III performance goals and procedures (10/2003) http://www.fda.gov/cder/pdufa/default.htm**
**Renewed every 5 years with some changes**

## Short Legislative History

**FD&C (1997) Modernization Act (PDUFA II)**
**Renewed PDUFA with some changes, e.g., structures meetings with industry plus others**
**Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PDUFA III)**
**Renewed PDFUA with some changes, e.g., Continuous Marketing Application Pilots plus others**

## Department of Health and Human Services

**Office of the Secretary**
**Administration for Children and Families**
**Administration on Aging**
**Agency for Healthcare Research and Quality**
**Agency for Toxic Substances and Disease Registry**
**Program Support Center**
**Substance Abuse and Mental Health Services Administration**

**Centers for Disease Control and Prevention**
**Centers for Medicare and Medicaid Services**
- Food and Drug Administration
**Health Resources and Services Administration**
**Indian Health Service**
**National Institutes of Health**

## Food and Drug Administration

**Office of the Commissioner**
**Center for Biologics Evaluation and Research**
**Center for Drug Evaluation and Research**
**Center for Devices and Radiologic Health**
**Center for Veterinary Medicine**
**Center for Food Safety and Applied Nutrition**
**National Center for Toxicological Research**
**Office of Regulatory Affairs**

## CBER Structure

**Office of Communication, Training and Manufacturers Assistance**
**Office of Management**
**Office of Blood Research and Review**

**Office of Cellular, Tissues and Gene Therapy**
**Office of Vaccines Research and Review**
**Office of Biostatistics and Epidemiology**
**Office of Compliance and Biologic Quality**

## Vision for CBER 

***Advancing Public Health***
**Protect and improve public and individual health in the US, and if possible, globally**
**Facilitate development, approval and access to safe and effective products**
**Strengthen CBER as preeminent regulatory Agency for biologics**

**Vision for CBER **

## LEGAL FRAMEWORK

**    ****STATUTES**
**    ****REGULATIONS**
**    ****GUIDANCE**

## STATUTES

**PUBLIC HEALTH SERVICE ACT**
**licensing provisions**
**prevent communicable disease **
**Federal Food, Drug and Cosmetic Act**
**Investigational New Drug Applications**
**Other Statutes**
**e.g. Administrative Procedure Act**
**Federal Advisory Committee Act**

## Regulations

**Created under statutory authorities (PHS Act and FDC Act)**
**Designed to implement, interpret, or prescribe law or policy**
**Establishes requirements**
**Has binding effect on both you and the Agency**

## Regulations of Interest

**Investigational New Drug application: 21CFR 312**
**Informed Consent 21 CFR 50 **
**Institutional Review Boards 21 CFR 54**
**Biologics 21 CFR 600**
**Tissues 21 CFR 1270/1271**
**Recalls 21 CFR 7**

## What is a Guidance Document?(21 CFR 10.115(b))

** ****A document that describes FDA’s interpretation of or policy on a regulatory issue; or**
**Relates to**
**The design, production, labeling, promotion, manufacturing, and testing of regulated products;**
**The processing, content, and evaluation or approval of submissions; and**
**Inspection and enforcement policies.**
**FDA’s current thinking on an issue**

## Guidance Documents

**Guidance documents are **_**NOT**_** regulations**
**Guidance documents **_**CANNOT**_** be enforced**
**You may chose an alternative approach **_**that complies with laws and regulations**_
**FDA can deviate from guidance but may do so **_**only **_**with supervisory approval**

## Practical Advice

**Make use of your resources!**
**Regulatory Compliance and Human Subjects Protection Branch**
**CBER is Here to Help You**
**On-line**
**On the telephone**

## Slide 18

## We’re Here to Help You!

**WWW.FDA.GOV/CBER **
**Email CBER:**
**Manufacturers: matt@cber.fda.gov**
**Consumers, health care professionals: octma@cber.fda.gov**
**Phone:  800-835-4709/301-827-1800**
**Listserv:  http://www.fda.gov/cber/pubinfo/elists.htm**

## We’re Here to Help You!

**Contact me via phone at: **
**	****	****	****301-827-0373**
**Or contact me via e-mail at: **
**	****	****	****Robert.yetter@fda.hhs.gov**