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Guidances
We Develop and Enforcement Information
Regulatory & Scientific Guidances
Specific Regulatory
Initiatives
Legislation
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. (Posted 3/6/2000)
- CDER
Small Business Assistance Program. What you
need to do to file an application for marketing a new drug
product. (Posted 3/6/2000)
- Electronic
Regulatory Submissions and Review (6/6/2000)
- 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. External link to HHS/FDA forms,
including Investigational New Drug Application, etc.
- FDA
Forms Public Use Forms and How to Obtain Them
- IND Form
Help: Information for Sponsor-Investigators Submitting Investigational
New Drug Applications (INDs) (1/13/1998)
- 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 (Updated 5/2/2001)
- Investigational
Human Drugs: Clinical Investigator Inspection List
(1/13/2003)
- Office of
Drug Evaluation IV: Pre-IND Consultation Program (Updated
11/14/2000). The ODE IV Pre-Investigational New Drug Application
(IND) Consultation Program is designed to facilitate and foster informal
early communications between the divisions of ODE IV and potential
sponsors of new therapeutics for the treatment of bacterial infections,
HIV, opportunistic infections, transplant rejection, and other diseases.
The program is intended to serve sponsors of all drug products that may
be submitted to the any division within ODE IV, including but not
limited to drugs for the treatment of life-threatening
illnesses.
- Office of Drug
Evalution IV: Pilot Targeted Product Information (11/14/2000)
. After a 12-month collaborative effort between FDA and the
Pharmaceutical Research Manufacturers Association (PhRMA), FDA’s Office
of Drug Evaluation IV (ODE IV) is piloting a tool that may improve the
drug development process.
- Required
Specifications for FDA’s IND, NDA, ANDA, Drug Master File Binders
(Updated 3/19/1998)
International Activities
CDER Policies & Procedures
Compliance Activities
Freedom of Information Act
Useful Resources
- Narcotic
Treatment Program Directory
 (2/9/2000).
Narcotic Treatment Programs Directory is a listing of all outpatient
maintenance/detoxification programs, and all inpatient detoxification
programs approved by the Food and Drug Administration for the treatment
of narcotic addiction using narcotic drugs. Methadone and LAAM are the
only narcotic drugs which have been approved for use in the treatment of
narcotic addiction. The Directory is a valuable source for those
individuals seeking treatment and for those medical professionals
referring patients to treatment. The Directory will be updated
quarterly.
Some of documents are in
Portable Document
Format (PDF) to retain the original format. To view or
print these documents, you must use the Adobe Acrobat viewer. Acrobat is
free and available directly from Adobe's website with full installation
instructions. 
[Accessibility]
FDA/Center for Drug Evaluation and
Research
Last Updated: July 7, 2003
Originator: OTCOM/DML
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