The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.
The FDA awards grants for clinical studies on safety and/or effectiveness of products that could either result in, or substantially contribute to, approval of the products.
The FDA is in a unique position to help those who suffer from rare diseases by offering several important incentives to promote the development of products for rare diseases, one of which is this grants program, said Gayatri R. Rao, M.D., director of the FDAs Office of Orphan Product Development. The grants awarded this year support much-needed research in difficult-to-treat diseases that have little, or no, available treatment options.
The program is administered through the FDAs Orphan Products Grants Program. This program was created by the Orphan Drug Act, passed in 1983, to promote the development of products for rare diseases. Since its inception, the program has given more than $330 million to fund more than 530 new clinical studies on developing treatments for rare diseases and has been used to bring more than 50 products to marketing approval.
A panel of independent experts with experience in the disease-related fields reviewed the grant applications and made recommendations to the FDA.
The 2014 grant recipients are:
For the grants program therapies, a disease or condition is considered rare if it affects less than 200,000 persons in the United States. There are about 7,000 rare diseases and conditions, according to the National Institutes of Health. In total, nearly 30 million Americans suffer from at least one rare disease.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###
Read more here:
FDA awards grants to stimulate drug, device development for rare diseases
- There Was a Loud Crunching Sound Bodybuilding Icon Ronnie Coleman, Who Went Through Stem Cell Therapy, Once Revealed Exact Moment His Back Problems... - October 13th, 2022
- Scientists have figured out how to reverse the ageing process in mice. Now theyre turning their attention to humans - 7NEWS - June 13th, 2022
- Here's what happened the first week of the Kyle Rittenhouse trial - NPR - November 8th, 2021
- College Student and Retired Teacher to Thank Stem Cell Donors They've Never Met for Saving Their Lives During City of Hope's 45th Bone Marrow... - October 16th, 2021
- 3D Printing Applications in the Fight Against Breast Cancer - 3Dnatives - October 16th, 2021
- The Mystery of Smell - Harvard Magazine - October 16th, 2021
- Blood donation clinic will honour life of Jocelyn McGlynn - Chatham Daily News - August 5th, 2021
- The 5G NR mmWave X factor (Analyst Angle) - RCR Wireless News - January 27th, 2021
- Kyle Rittenhouse's lawyers fight extradition in protest of turning him 'over to the mob' - Fox News - October 10th, 2020
- Nick Cordero's Wife Says His COVID-19 Recovery Is 'Going in the Right Direction' - countryliving.com - June 10th, 2020
- Ocular Technologies, a startup developing telemedical solutions to improve access to eye care, wins the 2020 MIT $100K Entrepreneurship Competition -... - May 29th, 2020
- Michael Hiltzik: Don't be taken in by stem cell firms offering unsubstantiated therapies for COVID-19 - Rome News-Tribune - May 14th, 2020
- The Shows Delayed, but Theyre Still Keeping Company - The New York Times - May 14th, 2020
- Coronavirus And Parenting: What You Need To Know Now - KPCW - March 14th, 2020
- 'His legacy lives on': Grandmother who helped create newborn screening law tells history of bill - News-Leader - March 6th, 2020
- The Dady Brothers, four others get their Rochester Music Hall of Fame call - WXXI News - February 27th, 2020
- Brit boy, 4, who survived leukaemia finally meets the German blood marrow donor who saved his life - The Sun - February 22nd, 2020
- Army spouse dances her way through chemotherapy - We Are The Mighty - February 22nd, 2020
- Before the 90 Days Stephanie is YouTuber Stepanka. Is she really ill & bi? - Starcasm - December 20th, 2019
- Stem Cells Video | Top 3 Stem Cell Videos on YouTube - January 15th, 2019
- FDA to crack down on 'unscrupulous' stem cell clinics - Minneapolis Star Tribune - August 29th, 2017
- Stem Celling Training to Oversee Onsite Training at Facility in Las Vegas - PRUnderground (press release) - August 24th, 2017
- R3 Stem Cell Achieves Certification by the Better Business Bureau - PR Web (press release) - August 7th, 2017
- Update: Laval police erased cellphone video of violent arrest, says disabled black man - Montreal Gazette - July 9th, 2017
- Cord Blood Stem Cells | What are Stem Cells? | Cryo-Cell - July 17th, 2016
- stem cells - Cosmetic Ingredient Dictionary: Cosmetics Cop ... - July 17th, 2016
- Stem Cell Therapy - Prolotherapy Institute Los Angeles - July 17th, 2016
- Stem cell - Simple English Wikipedia, the free encyclopedia - July 17th, 2016
- stem cell tourism | The Stem Cellar - July 17th, 2016
- Stem Cells flashcards | Quizlet - July 17th, 2016
- All Things Stem Cell Visual Stem Cell Glossary - July 17th, 2016
- Stem Cells and Parkinson's Disease | Parkinson's Disease ... - July 17th, 2016
- Stem-cell | Define Stem-cell at Dictionary.com - July 17th, 2016
- Academia.edu | Documents in Stem Cells - Academia.edu - July 17th, 2016
- How Umbilical Cord Stem Cells Work | ViaCord - July 17th, 2016
- Stem Cells - RCN - July 17th, 2016
- Microscope Imaging Station. Stem Cells: Cells with Potential. - July 17th, 2016
- Mesenchymal stem cell - Wikipedia, the free encyclopedia - July 17th, 2016
- anti-aging stem cells - Lucrece - July 17th, 2016
- Mesenchymal Stem Cells: Immunology and Therapeutic ... - July 17th, 2016
- What are Stem Cells? | Stem Cells | University of Nebraska ... - July 17th, 2016
- Stem Cell Key Terms | California's Stem Cell Agency - July 17th, 2016
- Stem Cell Transplants (For Parents) - KidsHealth - July 17th, 2016
- Induced pluripotent stem cell - Wikipedia, the free ... - October 23rd, 2015
- Stem Cells in MS - National Multiple Sclerosis Society - October 23rd, 2015
- STEM CELLS - Wiley Online Library - October 18th, 2015
- Manhattan Regenerative Medicine Medical Group - September 26th, 2015
- Stem Cells News -- ScienceDaily - September 7th, 2015
- Blood-Forming Stem Cell Transplants - National Cancer ... - August 29th, 2015
- Stem Cells: Get Facts on Uses, Types, and Therapies - May 31st, 2015
- StemCells, Inc. - Official Site - May 31st, 2015
- Stem Cell Basics: Introduction [Stem Cell Information] - May 31st, 2015
- Cell Isolation Products, Cell Culture Media, Cell Research - May 23rd, 2015
- What are Stem Cells ? - Medical News Today - May 19th, 2015
- LUMINESCE Stem Cell Skin Care - May 19th, 2015
- Stem cell therapy - Wikipedia, the free encyclopedia - May 19th, 2015
- Download Stem Cells and Cancer Stem Cells, Volume 6 PDF - Video - May 3rd, 2015
- Embryonic and induced pluripotent stem cells Part 2 - Video - May 3rd, 2015
- Treatment of Rotator Cuff tendinitis with Platelet Rich Plasma and Stem cells - Video - May 3rd, 2015
- Download Cancer Stem Cells Methods and Protocols PDF - Video - May 2nd, 2015
- What is leukemia? - Danilo Allegra and Dania Puggioni - Video - May 1st, 2015
- Stem Cell Treatment #5 for Multiple Sclerosis - Video - April 30th, 2015
- WHAT CAN STEM CELLS DO? - Video - April 30th, 2015
- Developing a cure for AMD - Video - April 30th, 2015
- Engineered Blood Vessel Network with Endothelial Cells (Red) and Mesenchymal Stem Cells (Green) - Video - April 29th, 2015
- Cynata making stem cells for therapeutic use - Video - April 29th, 2015
- Cellogica Stem Cell Review Gain A Healthy And Vibrant Looking Skin With Cellogica - Video - April 28th, 2015
- REGENESTEM MANILA: Stem Cells are Harvested - Video - April 26th, 2015
- Milk Thistle Inhibits Colorectal Cancer Stem Cells - Video - April 26th, 2015
- Hannah legs is better! - Video - April 26th, 2015
- Dr. Casper Stem Cells Grade 10 - Video - April 26th, 2015
- Jeunesse stem cells - anagenisis - team phoenix - Video - April 25th, 2015
- Mayo Clinic Transplant Center Regenerative Medicine Consult Service - Video - April 25th, 2015
- Lifeline, English Subtitles - Video - April 24th, 2015
- Dr.Nathan Newman Stem Cell Technology by JEUNESSE Global UAE, Dubai Abu Dhabi - Video - April 23rd, 2015
- Stem Cells Are Forced Out/ Cell, April 9, 2015 (Vol. 161, Issue 3) - Video - April 23rd, 2015
- Repairing Chronic Muscle Tears with Stem Cells - Video - April 23rd, 2015
- LUMINESCE by Jeunesse Global - Stem Cell Techology - Video - April 23rd, 2015
- Stem Cell Enhanced Facial Demonstration - Video - April 21st, 2015
- Adult stem cell bank for nuclear disaster! - Video - April 19th, 2015