CDER SBIA Update: New Guidance Documents

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

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New Guidance Documents

1. Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices

This revised draft guidance provides guidance on FDA's current thinking on recommended practices for drug or medical device manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines ((CPGs); all three collectively referred to as “scientific and medical publications”) that discuss unapproved new uses for approved drugs or approved or cleared medical devices marketed in the United States.

Guidance Document

Federal Register Notice

2. Drug Development to Treat the Symptoms of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis 

FDA is planning a series of activities focused on drug development to treat the symptoms of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). As part of these plans, FDA has released a draft guidance is to assist sponsors in the development of drug products for the treatment of CFS/ME.

FDA Drug Development for ME and CFS

Federal Register Notice

3. Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products  

This guidance clarifies the FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate packaging sizes for injectable drug and biological products. 

Federal Register Notice

Draft Guidance Document

 

4. Draft Guidance for Industry on Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations

This draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations” relating to BA and BE studies for INDs, NDAs, and NDA supplements. 

Federal Register Notice

 

5. Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

This draft guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter “accelerated approval”). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved.

Federal Register Notice

Draft Guidance

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The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

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