Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal Contraceptives

Description

Division of Reproductive and Urologic Drug ProductsOffice of Drug Evaluation IIDivision of Antiinfective Drug ProductsandDivision of Antiviral Drug ProductsOffice of Drug Evaluation IV

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2

Vaginal Contraceptives

drugs proposed to act as vaginal contraceptives

Topical Microbicides

intended to prevent sexually transmitted diseases (STD)

Stakeholders

1

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Regulatory Activities

2

NDA

New Drug Application

Investigational New Drug

IND submission supported by data

Technical Details

Substances

2

Octoxynol 9

development of octoxynol 9 products; NDAs for octoxynol 9 require efficacy information only

Nonoxynol 9

development of nonoxynol 9 products; NDAs for nonoxynol 9 require efficacy information only

Testing Methods

2

Genotoxicity Battery

standard battery of tests to evaluate all new molecular entities

Vaginal Irritation Tests

carried out in rabbits with daily applications for ten days

Processes

2

Pharmacokinetic/Toxicokinetic Studies

analyses performed to evaluate the drug's ADME profile

Toxicology Studies

Pivotal toxicology studies considering disease biology and pharmacology

Clinical Concepts

1

Sexually Transmitted Diseases

intended to prevent the transmission of STDs

Related CFR Sections (1)

21CFR10.90§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.
(a) Regulations. FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure of the study director to assure protocol compliance and accurate data recording

1

Failure of the study director to assure experimental data are accurately recorded and verified

1

Failure to properly identify specimens

1

Failure to assure experimental data were accurately recorded and verified

1

Failure to authorize and document deviations from standard operating procedures

1

QAU failed to assure reported results accurately reflect raw data

1

Failure to maintain a Quality Assurance Unit

1

Study director failed to assure protocol compliance and data accuracy

1

Fabrication of animal weight data

1

Failure to establish procedures for handling test and control articles

1