Vaginal Microbicides:Development for the Prevention of HIV Infection PDF | Guideline Explorer

Description

This guidance provides recommendations for the development of vaginal microbicides regulated within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for the prevention of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of vaginal microbicide drug products.

Scope & Applicability

Product Classes

5

Vaginal Microbicides

intravaginal drug products that reduce the risk of HIV acquisition; Development for the prevention of HIV infection

Vaginal Microbicide

preventive treatment for HIV infection

semisolid gel formulations

dosage form for vaginal microbicides

vaginal ring microbicides

drug delivery system for vaginal administration

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Stakeholders

5

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

7

Coitally Dependent Dosing

pre-coital dosing, or post-coital dosing

rheological characteristics

Attribute affecting drug product retention and distribution

Noninferiority margin

Justification essential for trials using a noninferiority design

Osmolarity

Physical attribute affecting mucosal integrity

viscosity

E-liquid design parameter affecting performance.

Coitally Independent Dosing

daily dosing, intermittent dosing, or sustained release

Therapeutic Index

the effective and nontoxic dose findings in the same animal species should be compared (i.e., the therapeutic index should be discussed).

Related CFR Sections (2)

21CFR50.52§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely tRead full regulation →
21CFR884.5300§ 884.5300 Condom.
(a) Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagRead full regulation →

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