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Compliance In Focus


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Posted by Tracey Tytko on Mon, Nov 06, 2017

The Future of the FDA: The Perception of a Clinical Research Associate

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?

Topics: FDA, CDRH, Robert Califf, Clinical Research Associate

Posted by John Lehmann on Thu, Dec 10, 2015

Combination Product Pathway

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.

Topics: Combination Products, FDA, Robert Califf, Product Pathway

Posted by John Lehmann on Wed, Aug 05, 2015

FDA Prioritizes Combo Product Reforms

Both companies and the FDA continue to be frustrated with the mismatches between drug and deviceFDA_Prioritizes_Combo_Product_Reforms-1 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.

Topics: Jeffrey Shuren, Combination Products, FDA, Robert Califf

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.