New Guidance Documents & Workshop: GDUFA Self-Identification/ REMS/ Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

1. Self-Identification of Generic Drug Facilities, Sites, and Organizations - Guidance for Industry

This guidance is intended to assist industry to meet the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.

Guidance Document

Federal Register Notice

2. Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary - Draft Guidance for Industry

This draft guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several being developed to fulfill performance goals that FDA agreed to satisfy in the context of the fifth re-authorization of the prescription drug user fee program (the Prescription Drug User Fee Act V).

Guidance Document

Federal Register Notice

3. Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry

This draft guidance is intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more closely in time. The draft guidance is intended to address concerns that new FDA-approved antibacterial drugs become available without needed FDA-cleared AST devices because of a potential time lag between the drug approval and device clearance.

Guidance Document

Federal Register Notice

4. Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - FDA Public Workshop

FDA is announcing a public workshop regarding Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs). This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The input from this public workshop will also help in developing topics for future discussion.

Date: September 29, 2016

Time: 9:00 a.m. to 4:00 p.m.

Location:  Silver Spring, MD  

For registration and more information, please visit: ASTs Public Workshop.