Rosen Quoted in Pink Sheet about New FDA Clinical Study Disclosure Program

18 January 2018 Pink Sheet News

Partner David Rosen was quoted in a Pink Sheet article, “Clinical Study Disclosures Will Make Drug Reviews More Efficient- Gottlieb,” about the implications of a new FDA program linking drug approval documents to sponsors’ clinical study reports.

Rosen said the opening the clinical study reports could help sponsors on the reimbursement end. “Third-party payers want to understand a lot of the underlying data that went into FDA’s decision-making process for new products that are coming into the marketplace because they have tough choices on reimbursement,” he said.

Rosen also told Pink Sheet that the willingness of sponsors to participate in the new program may depend on how much of the data will be made public. “I do really like the idea that more of the data…on which FDA has conducted their analysis to confirm safety and efficacy would be open to the public for examination,” he said. “I don’t think it’s meant to be a second-guess situation, too, but I think you’ll see a lot of people looking at this to do some comparative analyses of their product versus other products. It should be very interesting.”

(Subscription required to read the full article)

Related Services


5 Tips for Law Students Heading into Interview Season
03 August 2021
Foley Career Perspectives
Intellectual Property for Fashion and Beauty Consumer Products
03 August 2021
460,000+ Cybersecurity Professional Jobs are Available!
03 August 2021
Internet, IT & e-Discovery Blog
Foley Weekly Automotive Report
03 August 2021
Dashboard Insights
30th Annual Law of Product Distribution & Franchise Seminar
29 September | 7 & 20 October 2021
Milwaukee | Chicago | Dallas
7th National Telehealth Summit
4-5 October 2021
Miami Beach, FL
AHLA Fraud & Compliance Forum
21-22 September 2021
Baltimore, MD
2nd Clinical Trial Agreements Forum
16-17 September 2021
Online Livestream