Contents On This Page

• Regulatory & Scientific Guidances
• Specific Regulatory Initiatives
• Legislation
• Submitting Applications for New Drug Products
• International Activities
• CDER Policies & Procedures
• Compliance Activities
• Freedom of Information Act
• Useful Resources

Regulatory & Scientific Guidances

• Guidance Documents Web Page a searchable, topical guide to CDER guidance documents.
• The CDER Data Standards Manual The CDER DSM is a compilation of standardized nomenclature monographs that have been reviewed and approved by the CDER Nomenclature Standards Committee (NSC).
• Certificate of Pharmaceutical Product   The Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce" was revised in 1997. As a result, CDER revised its procedures for the issuance of Certificates for Pharmaceutical Products to firms that legally market drug products.
• Human Drug Current Good Manufacturing Practice Notes.  Human Drug Current Good Manufacturing Practice Notes is a periodic memo on Current Good Manufacturing Practice issues on human use pharmaceuticals, issued by the Division of Manufacturing and Product Quality.
• Pharmacology and Toxicology  Guidances for Industry
• Suitability Petitions  List of Petitions filed under section 505(j)(2)(C) of the Food, Drug and Cosmetic Act where the Agency has determined that the referenced product: (1) Is suitable for submission as an ANDA (Petitions Approved) or (2) Is not suitable for submission as an ANDA (Petitions Denied). 

Specific Regulatory Initiatives

• Class Labeling for Intranasal and Orally Inhaled Corticosteroid Containing Drug Products Regarding the Potential for Growth Suppression in Children
• Compressed Medical Gases Guidance Page
• Conjugated Estrogens
• Drugs Marketed in the United States That Do Not Have Required FDA Approval
• FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products. Information (1/10/2007)
• Final Rule on the Requirements for Prescribing Information for Drug and Biological Products
• Genomics at FDA
• Medical Imaging and Drug Developement Web Page
• Metered-Dose Inhalers
• Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
• Pharmacy Compounding Page
• Positron Emission Tomography (PET) Page
• Pregnancy and Lactatation Labeling
• Radioactive Drug Research Committee (RDRC) Program web page
• Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients: Final Rule.  Also in PDF . Draft version available under CDER Archives.

Legislation

• The Food and Drug Administration Amendments Act of 2007
• CDER Food and Drug Administration Modernization Act Page
• Code of Federal Regulation (CFR) Title 21. (FDA)A searchable version of the Code of Federal Regulations on the FDA site.
• Compilation of Laws and Related Statutes Enforced by The U.S. Food and Drug Administration
• Dietary Supplement and Non-prescription Drug Consumer Protection Act
• Federal Register (FDA). FDA-related material published in the Federal Register.
• Federal Register (GPO).  An external link to the entire text of the Federal Register (1995-current) on the Government Printing Office web site.
• Food and Drug Administration Amendments Act of 2007
• Food and Drug Administration Modernization Act of 1997 Also in PDF
• Food, Drug and Cosmetic Act
• Prescription Drug Marketing Act
• Prescription Drug User Fee Act Reauthorization Letter;  Performance Goals and Procedures
• Prescription Drug User Fee Act Related Documents

Submitting Applications for New Drug Products

• CDER Drug Product Applications.   What you need to know to file applications for a regular or an emergency investigational drug product, a new drug, or a generic drug.
• CDER Small Business Assistance Program. What you need to do to file an application for marketing a new drug product. 
• Electronic Regulatory Submissions and Review
• Electronic Records; Electronic Signatures (21 CFR Part 11).  These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to promote and protect public health. The use of electronic records as well as their submission to FDA is voluntary.
• FDA Forms Distribution Page; Public Use Forms and How to Obtain Them
• IND Form Help: Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
• Pre-IND Consultation Program: CDER offers a Pre-Investigational New Drug Application (IND) Consultation Program to foster early communications between sponsors and new drug review divisions in order to provide guidance on the data necessary to warrant IND submission. The review divisions are organized generally along therapeutic class and can each be contacted using the designated Pre-IND Consultation List.
• Institute Review Board Operations and Clinical Investigation Requirements.  This FDA Office of Public Affairs page provides information on IRB operations and clinical requirements.
• International Conference on Harmonization: Electronic Standards for the Transfer of Regulatory Information [external link]
• Investigational Human Drugs: Clinical Investigator Inspection List
• Required Specifications for FDA’s IND, NDA, ANDA, Drug Master File Binders

International Activities

• International Conference on Harmonization: Electronic Standards for the Transfer of Regulatory Information [external link]

CDER Policies & Procedures

• Manual of Policies and Procedures (MaPPs) CDER's official policies and procedures manual.

Compliance Activities

• Disqualified/Restricted/Assurance List for Clinical Investigators
  This list contains the names of all investigators who have at one time been disqualified, restricted, or have made assurances in their use of investigational products.
• Drug Application Regulatory Compliance
• Drug Registration and Listing
  • Drug Firm Annual Registration Status
• Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations
• Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Freedom of Information Act

• CDER Freedom of Information Office Electronic Reading Room

Useful Resources

• Substance Abuse Treatment Facility Locator