July 6, 2018

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Recent Posts

FDA Comments on Recently Released Rare Disease Guidance for Industry

September 16, 2015

Jonathan Goldsmith, M.D., F.A.C.P., FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, comments on the recently...

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Patagonia Awarded $1.5MM Grant from the FDA

September 18, 2018

Patagonia is excited to announce that we have been awarded a grant of $1.5MM over three years through FDA's Orphan Products Clinical Trials Grants Program!  This non-dilutive funding will help support our clinical development of PAT-001, a proprietary topical formulation of isotretinoin in development for Congenital Ichthyosis.   This is a highly competitive grant, generally awarded to less than 20% of applicants.  

 

The goal of FDA's Office of Orphan Products Development (OOPD) Orphan Products Clinical Trials Grants Program is to support the clinical development of products for use in rare diseases or conditions (a disease or condition that affects fewer than 200,000 people in the United States) where no current therapy exists or where the proposed product will be superior to the existing therapy.  FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products for rare diseases.

 

To view FDA's press release and review the full list of award recipients, you may follow the link below:

 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm621490.htm

 

For more information on FDA's Orphan Products Clinical Trials Grants Program, you may follow the link below:

 

https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/WhomtoContactaboutOrphanProductDevelopment/ucm134580.htm

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