- November 08, 2018
Developers of therapies that feature device and drug or biologic components can ask the FDA to classify their products. These classifications are based on the primary mechanism of action and determine how the regulator handles combination products. That process looks set to survive the first major review of the regulations since 1991. The reconsideration process has bleaker prospects.
The FDA will accept requests for reconsideration from companies that are unhappy with how the Agency has categorized their products. However, the applicant is prohibited from providing new information. The result is that the reconsideration process rarely results in revised classifications.
The impression that the reconsideration process is a waste of both sponsors and FDA’s time and energy is reinforced by the availability of a supervisory appeal option. Sponsors can take up this option as soon as the FDA delivers a verdict they want overturned. However, some sponsors think they have to go through the reconsideration process first, resulting in wasted time and effort.
That thinking led the FDA to conclude it would be “unhelpful” to retain the reconsideration process.
The Agency is proposing to cut it from the regulation as part of a broader overhaul of the text. The other changes are designed to clarify the scope of the document and align it with today’s legislative and regulatory environment.
REFERENCE: Fierce BioTech; 16 MAY 2018; Nick Paul Taylor