FDA Announces Plan to Release About 100 New Guidance Documents

For the calendar year 2016, CDER at FDA plans to release more than 100 new guidance documents in 15 areas of interest. The list of guidance documents is a good indicator of FDA-industry interactions and current areas of interest and this year’s list is no different. Several of these will be eagerly awaited by the industry. There is a guidance document in the works specifically on off-label uses that seems to address the new legal environment for discussing unapproved uses of FDA-approved products. Another interesting one is on social media advertisement. Then there is one on demonstrating interchangeability of biosimilars with the reference drug. Several of the planned guidance documents are for very specific uses such as for developing drugs for allergic and non-allergic rhinitis and ulcerative colitis, while others are for broad impact topics such as the one on clinical trials in pregnant women, multiple endpoints in clinical trials, and determining when to submit a generic drug application versus the 505(b)(2) new drug application. For all manufacturers, this is a must read list and topics to keep track of. If your work is covered under any of the topics on which FDA is working to create a guidance document, you need to be extra vigilant to the release of the applicable documents. Several of these guidance documents have been in the works for several years and a few draft guidance documents have already been released earlier this year. The guidance documents do not supersede the comments received in a meeting with the FDA. Ideally, if a relevant topic is listed, it is even more important to arrange a meeting with FDA to get a peek at what the FDA is thinking about your product area. Another important task is to sign up for FDA’s mailer for announcement on new guidance document release.