This page provides a list of documents that may be downloaded directly from this Website.  It also provides links to government and other Websites that may be of interest.

DOWNLOAD DOCUMENTS

The document files below are in Adobe Portable Document Format (.pdf).

Selected Regulations

• 21 CFR 11:  PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

• 21 CFR 58:  PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES (GLPs)

• 21 CFR 210:  PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL (cGMPs)

• 21 CFR 211:  PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS (cGMPs)

• 21 CFR 310:  PART 310—NEW DRUGS

• 21 CFR 312:  PART 312—INVESTIGATIONAL NEW DRUG APPLICATION (IND)

• 21 CFR 314:  PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG (NDA)

•  21 CFR 600:  PART 600—BIOLOGICAL PRODUCTS: GENERAL

• 21 CFR 610:  PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS

• 21 CFR 803:  PART 803—MEDICAL DEVICE REPORTING

• 21 CFR 809:  PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

• 21 CFR 812:  PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS (IDE)

• 21 CFR 814:  PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES (PMA)

• 21 CFR 820:  PART 820—QUALITY SYSTEM REGULATION (QSR)

• 21 CFR 860:  PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES

• 21 CFR 1271:  PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS

• 42 CFR 493:  PART 493—LABORATORY REQUIREMENTS (Clinical Laboratory Improvement Amendments of 1988 - CLIA)

• California SHERMAN FOOD, DRUG AND COSMETIC LAWS

Selected Guidance Documents

• CBER/CDER Guidance:  INDs — Approaches to Complying with CGMP During Phase 1 (2006)

• CDER Guidance:  Exploratory IND Studies (2006)

• CBER Guidance:  Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (2004)

• CBER/CDER Guidance:  Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (2006)

• CBER/CDER Guidance:  Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (2004)

• ICH/FDA Guidance:  Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (2001)

• CBER Guidance:  Cooperative Manufacturing Arrangements for Licensed Biologics (1999)

• ORA/CDRH Guidance:  Guide to Inspections of Quality Systems (1999)

• ICH/FDA Guidance:  E6 Good Clinical Practice:  Consolidated Guidance (1996)

WEBSITE LINKS

Links to the FDA and other US Regulatory Websites

• FDA Home Page

• CBER Home Page

• CDER Home Page

• CDRH HOME PAGE

• FDA/ORA (Office of Regulatory Affairs - FDA Field Operations)

• FDA Search Page

• CLIA - Clinical Laboratory Improvement Amendments

• CDC Home Page

• NIH - rDNA and Gene Transfer

• NIST-National Institute of Standards and Technology

• The Code of Federal Regulations

• Federal Register

• FDB (California Food and Drug Branch)

Foreign Regulatory Agencies and other Regulatory Websites

• Health Canada -Health Products and Food Branch

• EMEA (EU Regulatory Body)

• EU cGMPs

• Japan Ministry of Health, Labour and Welfare

• ICH Home Page

• WHO/OMS: World Health Organization

Commercial/Professional Websites

• 21 CFR Part 11 Compliance Website

• AABB - American Association of Blood Banks

• ATCC (American Type Culture Collection)

• BioPharm International

• FACT (The Foundation for the Accreditation of Cell Therapy)

• Fallbrook Engineering

• FOI Services (Source for FDA Inspection Results)

• IBC USA Conferences Inc

• IEST (Institute of Environmental Sciences and Technology)

• ISCT (International Society for Cellular Therapy)

• ISO (International Organization for Standardization)

• ISPE (International Society for Pharmaceutical Engineering)

• Merchant-Taylor International

• Netcord-FACT

• PDA (Parenteral Drug Association)

• U.S. Pharmacopeia

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