CDER Small Business Update: Recent FDA Guidances, Actions, and Meetings

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business

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Recent FDA Guidances, Actions, and Meetings

 

1. FDA takes two important actions on drug shortages

 

FDAis taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. 

First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.

Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA. 

 

2. Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the development of new antibacterial drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes the revised draft guidance of the same name issued on August 27, 2010.

Federal Register

Guidance Document

 

3. Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment

The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a previous draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment” issued on September 14, 2010.

Federal Register

 

Guidance Document

 

4. Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment

The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination.

Federal Register

Guidance Document

 

 

5. Medical Gas Regulation Review; Announcement of Public Meeting

FDA is announcing a public meeting on whether any changes to Federal drug regulations are necessary for medical gases. The topic to be discussed is whether any changes to the Federal drug regulations are necessary for medical gases as part of the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA).
Date and Time: The meeting will be held on December 6, 2013, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the meeting may be extended or may end early.
Location: The meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002.

For additional information: Medical Gas Regulation Review Public Meeting

 

6. Public Workshop – Complex Issues in Developing Drug and Biological Products for Rare Diseases

The purpose of the workshop is to discuss complex issues in clinical trials for developing drug and biological products (“drugs”) for rare diseases, including endpoint development and selection, use of surrogate endpoints and the accelerated approval pathway, clinical trial design, conduct and analysis, safety considerations, and dose selections; and to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases. FDA is seeking input on these topics from academic, clinical, and treating communities; patients and advocacy groups; industry; and government agencies.
Date and Time: The meeting will be held on January 6-7, 2014; from 8 a.m. to 5 p.m.
Location: The meeting will be held at FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503 (Great Room), Silver Spring, Maryland 20993