Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 10 November 2014 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) regularly convenes panels of its various Advisory Committees to offer the agency advice on a wide range of regulatory topics—everything from general policy recommendations to specific advice on a particular drug or drug class.
In general, those panels—and the advice they dispense—is open to the public. For example, per 21 CFR 314.430(d), most drug products being assessed by FDA's advisory committees are open to the public and are closely watched by public health officials and analysts alike since FDA often adopts the advice dispensed by the committees.
However, not all of FDA's advisory panels are open to the public.
Case in point: one highly unusual meeting of FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (RUDAC) and the Drug Safety and Risk Management Advisory Committee (DSRMAC), both of which are set to confab during a secretive meeting on 18 December 2014.
The topic, according to a Federal Register notice published last week, will be a discussion of "whether FDA should permit further clinical development of an existing investigational drug product."
That two of FDA's advisory committee panels are weighing in on a drug's safety and efficacy isn't new—they do so practically on a weekly basis. What is unusual, however, is that the panels are assessing a drug that is only seeking to enter into the clinical development stage through a sought-after investigational new drug application.
Because FDA is legally required to protect a drug's commercial confidential information and a company's trade secrets, this means that unlike drug products seeking final approval from FDA, the agency also isn't allowed to divulge the name of the drug the panel is set to assess.
Even the name of the drug's sponsor isn't being divulged. While the public will have an hour to make oral presentations at the meeting, it would presumably be difficult to make informed comments since nothing is known about the product or its sponsor.
Some information about the product may be gleaned by reading between the lines of FDA's notice, however. The agency indicates the committee will be discussing "whether FDA should permit further clinical development of an existing investigational drug product." They key words there—"further" and "existing"—implies the product may have been subject to a clinical hold because of a safety issue. That line of reasoning seems to be supported by the involvement of FDA's DSRMAC, which generally only weighs in on safety issues.
The involvement of FDA's RUDAC would seem to further limit the universe of drugs potentially involved in the meeting, though for now, further speculation is just that—speculation.
FDA's Federal Register Notice
Tags: Advisory Committee Meeting, AdComm, FDA Advisory Committee Meeting, Secret, RUDAC, DSRMAC