OWC Pharmaceutical Research Corp (OWCP)

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Per following report, it seems Israel is already in the group of countries that FDA works with their clinical trials!

And we know the OWCP Skin Disorder cream has already completed its Safety Trial successfully!

"FDA Perspective on International Clinical Trials


Kassa Ayalew, M.D., M.P.H.
Acting Branch Chief
Division of Good Clinical Practice Compliance
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research Food and Drug Administration

Clinical trials are increasingly conducted outside US

What Drives Companies to Conduct Clinical Trials Outside the USA?

Leveraging Knowledge and Resources

Utilize finite resources strategically and efficiently, leverage inspection resources ( Observe each other inspection, conducting joint inspection, provide parallel advice to sponsors, participate in regular discussions)
Share knowledge and information (inspection reports)
European Medicines Agency (EMA), European National Inspectorates, Health Canada, Japan’s PDMA, Korea’s KFDA, China’s SFDA, Singapore’s HAS, Argentina’s ANMAT, New Zealand, South Africa, Israel, India, Jordan, Thailand

Pulling Forces

• Lower operational costs (clinical, salaries, rental) • Availability of large # of patients – Rx naïve subjects willing & eager to participate • Availability of CROs focused on global trials • Faster recruitment rates/ short timeline • Fewer logistical problems (contract & bureaucracy, reduced regulatory barriers) • Widespread adoption of the (ICH-GCP) guidelines & stronger intellectual property protections

Pushing Forces

Difficulty recruiting patients
Fewer feel need to participate
Higher standard of care
Mistrust (historical infamy Tuskegee trial)
Requirement for larger # of Pts
Insurance precluding participation/Liability /HIPAA
Economic Drivers
Costs: clinical care/Operational/bureaucratic (compliance, documentation & training)"

https://www.fda.gov/media/87406/download