The FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and Research (CBER) have published their 2015 guidance agendas, identifying key topics for which Industry can expect direction this year.
The CDER’s agenda includes 91 new or revised guidances in 14 categories ranging from Clinical/Statistical to Electronic Submissions. In the Advertising category, subjects include the recently released “Revised Draft Guidance on Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs,” as well as forthcoming guidances on pre-dissemination review for DTC TV ads, the use of healthcare economic information and providing submissions in electronic format. The agenda also includes a highly anticipated social media guidance on use of links that was laid over from 2014. The 2015 agenda provides a clearer picture of what manufacturers can expect from the guidance by extending its title to specify that it will deal with “Use of Links to Third-Party Sites.” This social media guidance, along with one titled “Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products,” will likely confront some of the challenges Industry must manage when attempting to exercise the right to distribute truthful information about products while complying with strict regulations on manufacturers’ speech.
At CDRH, the published agenda includes not only forthcoming new drafts but also plans to release final guidances. The agenda is prioritized according to an A-List of primary focus; a B-List that will be published as resources permit; and a list of guidances from 10, 20 and 30 years ago that are subject to retrospective review. Among the draft guidance topics on the A- and B-Lists are several that deal with the regulation of digital health technologies. As a draft on general wellness products has already been released, it seems clear that the FDA intends to leave regulation of low-risk technologies that do not make health claims to FTC. Scheduled drafts also include “Benefit-Risk Factors to Consider when Reviewing IDE Submissions,” “Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements” and “Adaptive Design for Medical Device Clinical Studies,” all of which have the potential to affect the path toward marketing clearance or approval.
CBER’s agenda includes 11 draft and final guidances in three categories. The Blood and Blood Components section deals with such headline-hot issues as blood donor eligibility and the Ebola virus, while the Cellular, Tissue, and Gene Therapy category contains guidances on gene therapy and HCT/Ps. A single guidance occupies the third category. About electronic submissions, it is one of many that the FDA has released in recent years to bring its procedures into the Digital Age.