Orphan Drug products give patients with rare diseases hope. The Orphan Drug Act, originated in 1983, features incentives for companies to develop drugs to treat a rare disease or condition by giving tax credits on clinical trials, eligibility for seven years of market exclusivity and no user fees. More and more companies are jumping on this bandwagon which no doubt means a demanding number of requests for the FDA to review. FDA continues to work on their review processes as Gayatri Rao, M.D., J.D. explains in her recent article on the FDA voice. Her message to companies is to prepare designation requests with much attention to detail and requirements. This preparation will minimize the number of review cycles needed with the FDA and get the therapies to the patient faster. Call on Pearl Pathways to work with you and provide the attention to detail you require in your orphan drug designation requests.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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