Overview
Combination products hold tremendous promise for enhancing patient care. 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 comprise 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 the 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
Insights
- Media CoverageDavid Shillcutt Quoted in “Proposed Digital Therapy Codes Good Idea with Barriers: Experts”2 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- Media CoverageAlaap Shah Quoted in “Don’t Worry, You (Probably) Won’t Have to Deal with ONC: Algorithm Transparency Rule May Have ...2 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 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