Compliance In Focus

There are many stakeholders involved in conducting a clinical trial today; however, there can be many challenges to the infrastructure of running a clinical trial. Challenges that are seen with running medical device trials can vary anywhere from securing funding to lacking time and having dedicated study personnel. Another challenge that is faced is the time to market new devices that are ensured to have safety, quality and effectiveness. Although protecting human research subjects is the top of all priorities, can this regulatory pathway be shortened?

During his November 17th conformation hearing at the Senate Health, Education, Labor and Pensions Committee FDA commissioner nominee Robert Califf indicated that the FDA could have a new combination pathway ready for approval within a year.  He is trying to replace Margaret Hamburg, who left the FDA back in April.

During the hearing Califf agreed that the FDA’s existing structure for reviewing combination products is not suitable.  “It’s a strong view at the FDA that we need another pathway that will give the FDA the flexibility to require the data that’s needed to ensure the public the proposed treatment is safe and effective.

Both companies and the FDA continue to be frustrated with the mismatches between drug and device regulations along with the communication challenges between the product centers that lead to inefficiencies.  FDA officials are signaling that the combination products review process is ready for reform and the 2017 user fee authorizations offer a good opportunity to make much needed changes.