New FDA Guidances to Inform Clinical Research

The Food and Drug Administration plans to issue numerous draft and final guidances in the coming months that aim to clarify processes for developing new therapies and for conducting clinical trials. The agenda for new and revised guidances for the Center for Drug Evaluation and Research (CDER) for 2014 [available at www.fda.gov.] calls for documents on developing new analgesics, drugs for rare diseases, and infectious disease treatments. The agency also proposes specific advice on testing new therapies for treating uncomplicated gonorrhea, chronic fatigue syndrome, and for conducting and submitting virology studies related to antiviral drug development.

Sponsors and CROs will be particularly interested in a document that outlines information needed by CDER’s Division of Good Clinical Practice Compliance to facilitate BIMO inspection planning and conduct. And FDA hopes to offer advice to clinical sponsor- investigators on preparing and submitting investigational new drug applications.

The research community stands to benefit from documents that address certain scientific and ethical considerations, such as including pregnant women in clinical trials, designing and analyzing clinical lactation trials, statistical analysis of multiple study endpoints, and setting standards for using imaging endpoints in clinical studies. FDA also plans advice on submitting standardized study data electronically. And a number of guidances will aim to clarify labeling: content and format of the “indications and usage” section; drugs approved under accelerated approval; pediatric information; content and format of pregnancy and lactation information;  and specifics related to the “highlights” section of the label.

Further information on developing biosimilars is expected, including a much-anticipated advisory on demonstrating interchangeability to a reference product. Other topics include biosimilar labeling, producing pharmacology data, and reference product exclusivity. FDA also plans to clarify best practices in developing proprietary drug names and on distributing drug samples. And there will be advice on identifying suspect products and on tracking drugs, as required by the Drug Quality and Security Act.

Three additional guidances on Internet/social media communications are scheduled for the coming year – one on presenting risk and benefit information in limited space, another on correcting independent/third party misinformation about a drug or medical device, and the third on appropriate use of links. A long-discussed document on using the “brief summary” to disclose drug risk information may emerge, as well as more specifics related to requiring and developing Risk Evaluation and Mitigation Strategies.