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Office of Antimicrobial
Products (OAP) Pre-IND Consultation
Program
What is the OAP Pre-IND Consultation
Program?
Established in 1988, the Office of Antimicrobial Products (OAP)
formerly known as the Office of Drug Evaluation IV (ODE IV) 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 with the
FDA Topical Microbicide Working Group.
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 at:
http://www.fda.gov/cder/ode4/preind/getting.htm
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.
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Date created: September 8, 2004, updated August 27, 2008 |
