Regulatory Strategy for Drug-Led Combination Products (NCRAF Spring Symposium)

An initiative connecting military talent with job opportunities in North Carolina’s growing biopharmaceutical manufacturing industry will expand, thanks to a new federal grant.

The two-year, $825,000 grant, awarded by the U.S. Department of Labor’s Employment and Training Administration, will be used to increase access to job training, internships and referrals across the state through the Military Outreach and Veterans Engagement (MOVE) initiative, launched in 2019 by the North Carolina Biotechnology Center. 

The North Carolina Biotechnology Center has helped hundreds of companies achieve amazing milestones over four decades. It’s only fitting that the state’s thriving life sciences sector stop and recognize NCBiotech’s own milestone on the 40th anniversary of its founding.

The regulatory strategy for the combination product is critical for guiding activities from development through lifecycle management of combination products. This presentation focuses primarily on the development and refinement of the regulatory strategy and submission planning and execution for drug Primary Mode of Action (PMOA) combination products, which combine a drug or biological product with a medical device. Many of the concepts discussed can also be applied to device PMOA combination products and to drug-biologic combination products.