Overview
Combination products hold tremendous promise for enhancing patient care, and as innovation in this space continues to progress, the U.S. Food and Drug Administration (FDA) is seeing a growing number of combination product submissions. However, because combination products are comprised of components (e.g., drugs, devices, and biologics) that are typically managed by different FDA centers, the review, approval, and post-market requirements related to these products can present a host of challenges for sponsors. Epstein Becker Green is adept at recognizing these challenges and helping clients navigate the complex regulatory, policy, and review management issues that can arise.
We have represented dozens of companies in their development of combination products. Also, given the complex regulatory environment, Epstein Becker Green created, launched, and continues to lead the Combination Products Coalition, a group of leading drug, biological product, and medical device manufacturers whose mission is focused on working collaboratively with FDA to improve the regulatory environment for combination products.
By partnering with Epstein Becker Green, clients benefit from our robust network of regulatory affairs contacts, quality consultants, reimbursement experts, compliance professionals, policy analysts, strategists, and other professionals who concentrate on providing coordinated guidance and solutions across various segments of the health care industry.
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Insights
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New ...5 minute read
- PublicationsFDA Significantly Reforms Cosmetics Regulations for First Time in Over 80 Years11 minute read
- Firm Announcements
Epstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law
2 minute read - PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program” ...2 minute read
- Media CoverageBradley Merrill Thompson Featured in “Meet the Top 8 Lawyers Helping Startups Patent Artificial Intelligence and Comply ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Ends Pre-Cert but Could Revisit in the Future, with Congress’ Help” ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”4 minute read
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- Media CoverageBradley Merrill Thompson Quoted in “FDA Issues Long-Awaited Draft Software Guidance in Overhaul of 16-Year-Old ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future” ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “UK Seeks Overhaul of AI, Software as a Medical Device Regs”3 minute read