Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted on two key proposed rules from FDA’s Office of Combination Products that have received Office of Management and Budget approval and are expected to soon be out for comment.
The article, “Combination Product Rules Clear OMB, To Be Released In Weeks,” stated that release of the proposed rules on current good manufacturing practices (cGMP) and adverse event reporting for combination products has been repeatedly delayed, most recently by the change in FDA leadership under the Obama administration.
Once the proposed cGMP rule comes out, the Combination Product Coalition trade group plans to organize a public meeting with FDA and regulatory professionals to discuss the regulation and work through real-world case studies, said Thompson, who is general counsel for the Coalition.
The Office of Combination Products is also preparing to review comments on its April draft guidance on technical considerations for injectors used with drugs and biologics.
The Combination Products Coalition criticized the draft for being too broad to be useful, but FDA clarified that it will issue separate draft guidance on regulatory pathways and jurisdictional issues for auto-injectors that may answer some of those concerns.