Pre-IND Consultation Program

What is the Office of Antimicrobial Products (OAP) Pre-IND Consultation Program?

Established in 1988, the Office of Antimicrobial Products (OAP) Pre-Investigational New Drug Application (Pre-IND) Consultation Program is designed to facilitate and foster early communications between the divisions of OAP and potential sponsors of new therapeutics for the treatment of bacterial, fungal, and viral infections, opportunistic infections, emerging infections (including naturally emerging diseases and potential biothreat agents), topical microbicides directed at prevention of HIV transmission, and transplant rejection. (21 CFR 312.82(a)).

Pre-IND advice may be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology, toxicology, and drug activity studies, including design and potential uses of any proposed treatment studies in animal models; data requirements for an Investigational New Drug (IND) application; initial drug development plans, and regulatory requirements for demonstrating safety and efficacy. Included among the OAP Pre-IND Program activities are coordination of all Pre-IND interactions for topical microbicides.

We encourage all potential drug sponsors or investigators to examine the information available from this site and to initiate contact with us as early in the drug development process as possible, so that they will have the opportunity to consider our recommendations in planning preclinical and clinical development programs.

How Do I Obtain Further Information Regarding the Program?

Please contact the appropriate Division for further information and specific contact information.

The Division of Antiviral Products (DAVP) is responsible for:

• HIV and AIDS (including antiretroviral therapy and Prevention of HIV transmission by topical microbicides)
• Hepatitis (HBV and HCV)
• Herpesviruses
• Emerging viral infections (including but not limited to respiratory viruses, zoonoses, and potential biologic threat agents)
• Other non-life-threatening and life-threatening viral infections

For more information, please visit the DAVP Web page.

 

The Division of Special Pathogen and Transplant Products (DSPTP) is responsible for:

• Quinolone antimicrobials
• Antimycobacterial drug products, antiparasitic
• Drug products (including malaria)
• Certain drug products for the treatment of H. pylori infection
• Drug products for treatment of HIV-associated opportunistic infections
• Drug products for the treatment of systemic and vaginal fungal infections
• Drug products for the treatment and prevention of organ transplant rejection
• Certain drug products for the treatment of chronic fatigue syndrome

For further information regarding the Letter of Instruction for the Division of Special Pathogen and Transplant Products, please call 301-796-1600.

The Division of Anti-Infective and Ophthalmology Products (DAIOP) is responsible for:

• Most systemic and topical antimicrobials
• Topical antiseptics
• Drug products for the adjunctive treatment of sepsis
• Drug products for treatment of Lyme disease

For more information please call 301-796-1400.

Note: Pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate. Additions or modifications to these communications may arise as additional information becomes available, during follow-up pre-IND interactions or when an IND is established.

For the Pre-IND Consultation Program, please contact the appropriate division referenced on the CDER Pre-IND Consultation Contact List (PDF - 29KB)