💊FDA Guidance on Antibacterial Therapies for Unmet Medical Needs
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers." This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)" issued on May 24, 2022.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The guidance facilitates the development of new antibacterial drugs, impacting businesses involved in pharmaceutical development and compliance with FDA regulations. It emphasizes the FDA's support in expediting drug development for serious conditions, which could lead to increased market opportunities for relevant firms.