Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in The Gray Sheet on the FDA’s proposed “streamlined approach” to combination product manufacturing.
The article, “Company Questions Remain Unanswered In FDA’s Combo Products GMP Rule,” stated that the proposed approach raises practical questions, such as what elements are actual components of a combination product and at what stage the streamlined system kicks in. Combination-product makers and other industry representatives met with FDA officials Jan. 12 to discuss the proposed rule and work through case studies to test the rule in action.
Manufacturers want more flexibility in deciding whether certain proposed additional requirements should apply to their product.
Thompson pointed out that while working through the case studies, for example, the workshop participants found that following the streamlined approach sometimes led to “overkill.”