Research development

Research development for rare diseases supported by FDA grant approval

The US Food and Drug Administration (FDA) recently approved funding of more than $23 million, to be spread over four years, to conduct 21 clinical trials of possible treatments for people suffering from rare conditions.

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An FDA representative said that the organisation was proud of its history in supporting research and contributing to the development of effective and safe tools to combat uncommon afflictions. The representative added that funding for the trials would support vital study into 21 areas of research related to unusual diseases.

Supporting research

The funding was awarded to these studies through the FDA’s Orphan Products Clinical Trials Grants Program, to help with the advancement of technology, drugs or other treatments.The FDA has made many public commitments to the importance of research, including getting behind more investigation into how the sexes respond differently to medications and health challenges, according to this report from The Guardian.

Necessary treatments

Since 1983, the Orphan Products Clinical Trials Grants Program has supported more than 590 clinical trials and contributed some $370 million to this research. As a result, more than 50 items have been released on to the market. Five trials in 2015 lead to approval of products used to treat ailments such as hypoparathyroidism, neuroblastoma and lymphangioleiomyomatosis.

More than 40 per cent of the funding awarded this year will go to studies on pediatric cases, some patients being newborn babies. Part of this research will focus on issues related to transplants.

Another project comprises looking at a medical aid that could be developed as a transplantable device to allow grasping and reaching functions in patients suffering with spinal cord injuries. This device could potentially allow patients to have more use of their arms and trunks.

If you are considering taking a medical product to market you may need to know more about the FDA 510k clearance process and it would be useful to consult experts, such as FDA third party review for specialist guidance.

The FDA operates to safeguard public health by regulating a vast range of drugs available on the market, and protecting the security of the food supply chain, along with a range of other products. By investing in research, the body is also making a significant contribution to dealing with effects of many debilitating diseases and conditions.