Bradley Merrill Thompson Quoted in “Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews”

RAPS Regulatory Focus

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in RAPS Regulatory Focus, in “Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews,” by Ana Mulero.

Following is an excerpt:

US Food and Drug Administration (FDA) draft guidance on combination products’ premarket review principles needs further clarity on a range of issues, according to commenters.

The public comment period on the February draft guidance—a document tasked with implementing goals set forth under section 3038 of the 21st Century Cures Act of 2016—closed earlier this week.

Commenters show appreciation for FDA’s efforts to serve such goals of greater “clarity, predictability and consistency” but they call on the agency to further address confusion, with one commenter going as far as requesting a redraft.

Bradley Merrill Thompson, an attorney at law firm Epstein Becker Green, says the Combination Products Coalition (CPC) believes that the draft “has the potential to drive increased efficiency and consistency in the premarket review of combination products, leading to benefits realized both by sponsors and FDA.”