North America Websites

United States Food & Drug Administration:    FDA Electronic Reading Room:

FDA Electric Orange Book: Approved Drugs Products:    FDA Pharmacogenomic Data Submissions

Center For Biologics Evaluation and Research (CBER):For Biologics   CDER Electronic Regulatory Submissions and Review (ERSR)    Center For Food Safety and Applied Nutrition: (CFSAN): Cosmetics    Food Safety Programs: Federal Register, Code of Federal Regulations

Drug Approval Process: FDA   Field Operations: FDA's Office of Regulatory Affairs (ORA): Information on Import program, ORA intervention, warning letters, inspection reports and FDA 483

Freedom of Information: FDA electronic FOI reading room.    Human Drug: Center for Drug Evaluation and Research (CDER): Drug Information, Regulatory Guidance, CDER Calender, Specific Audiences, CDER Archives, free internet based educational seminar.     Green Book: List of Approved Animal Drug Products

Human Drug cGMP Notes    Investigational New Drug Application (IND)

Medical Devices/Radiological Health: Center for Devices and Radiological Health (CDRH)
MedWatch: Reporting form and quidance, medical product safety information, safety alerts

Prescription Drug User Fee Act: FDA Modernization Act, generic drugs and Postmarketing Surveillance

    Veterinary Products: Center for Veterinary Medicine (CVM):Antimicrobial resistance, biotechnology, aquaculture, food safety, CVM Updates, FDA Veterinarian newsletter

Other Important Websites:

Center for Medicare and Medicaid Services: Information on Helathcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) drug codes.

Department of Health and Human Services: Information on diseases and conditions, drug and food information, reference collections.

International Conference on Harmonisation (ICH): Draft and Final ICH guidances.

National Center for Toxicological Research: Information on toxicity of products regulated by FDA.

RegSource: Worldwide regulatory, clinical, toxicological, CMC, information on FDA, European Medicines Agency (EMEA), Canada's Health Products and Food Branch (HPFB).

Standards Development:

Orange Book: Approved Drug Products with Therapeutic Equivalance Evaluations.

United States Pharmacopeia (USP)-National Formulary (NF):Official compendium of the pharmacy and medical profession.

United States Pharmacopeia Drug Information (USP DI): Information on drugs,

Regulations and Guidelines:

21 CFR Part 500: Veterinary Products 21 CFR Part 300:Drugs 21 CFR Part 600: Biologics

21 CFR Part 800:Devices

Record Retention:
21 CFR Part 11:Electronic Records 21 CFR 58.195:Nonclinical laboratory research records

21 CFR 211.180:Manufacturing Records for Drugs. 21 CFR 211.198:Drug product complaint records.

21 CFR 312.57 and 312.62:Clinical Investigation Records. 21 CFR 320.36:Records of Bioequivalence Testing

21 CFR 600.12:Manufacturing Records for Biologics 21 CFR 820.180:Manufacturing Records For Devices

Good Laborotory Practice Regulations:

Center for Devices and Radiological Health (CDRH)

Good Clinical Practice Regulations:

21 CFR Part 50: Protection of Human Subjects 21 CFR Part 54: Financial Disclosure by Clinical investigators 21 CFR Part 56: Institutional Review Boards 21 CFR Part 312: Investigational New Drug Application 21 CFR Part 314: Applications for FDA Approval to Market A New Drug 21 CFR Part 601: Applications for FDA Approval of a Biologic License.

Medical Device Submissions and Compliance:

21 CFR 807.81: Premarket Notification 510(K)

How to prepare a traditional 510(K)

21 CFR Part 812: Investigational Device Exemptions. IDE

21 CFR Part 814: Premarket Approval Application of Medical Devices.

21 CFR 820: The Quality System Regulation 21 CFR 820.180: General Records

21 CFR 820.198: Complaint files

21 CFR 860: Rule and Procedures for Establishing device classification and request a classification change.

Device Classification:Three classes of devices were defined that require increasing levels of regulatory control:

Class I: General Controls Class II: General Controls and Special Controls

Class III: General Controls, Special Controls and Premarket Approval.

Device Classification on CDRH

Good Manufacturing Practices:

The most fundamental GMP concept is that quality cannot be tested into a product; it must be designed and built in. A commonly accepted approach to GMP complaince is via "Systems Approach" which involves the interrelationship of objects, raw materials, in-process, finished producs, containers, equipment, processes, procedures and people. ---A quality system.

21 CFR 210: cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs.

21 CFR 211: cGMP for Finished Pharmaceuticals.

21 CFR 211.22, 820.22: A strong quality organization is critical element of GMP complaince.

21 CFR 211.42: Discus a GMP-compliant facility: Suitable size with temperature and humidity controls, with sewage and sanitation facilites. There shall be designated areas for quarantine, release and reject material.

21 CFR 211.80: Written procedures shall be followed for the receipt, storage, testing and approval/disapproval of components, product containers and closures.

21 CFR 211.160: Scientifically sound stability programs must be in place for each product to support labeled expiration date.

21 CFR 606: cGMP for Blood and Blood Components.

21 CFR 7: Enforcement Policy

21 CFR 820: Medical Device Quality System Regulations.

Combination Products:

FDA: Office of Combination Products (OCP) for informal source of jurisdictional information on combination products.

21 CFR Part 3: Request for Designation of combination products.

International Conference on Harmonization:

ICH Q7A: Step 5. Guidance for Industry Q7A Good Manufacturing Practice Quide for Active Pharmaceutical Ingredients.

Asia Pacific Regions:
Australia Government: Department of Health and Aging

Australia Govenrment: Therapeutics Good Administration

Food Standards: Australia and New Zealand