Woolsey Pharmaceuticals (Woolsey) is a clinical-stage pharmaceutical company focused on discovering and developing novel drugs for neurodegenerative diseases. Woolsey conducts human clinical trials to show that its investigational products are safe and effective. The data from these trials will be used to support marketing applications submitted to the U.S. Food and Drug Administration (FDA) and other regulatory authorities.
Section 3032 of the 21st Century Cures Act aims to make it easier for patients to understand a drug manufacturer’s policies regarding availability of its investigational new drugs for expanded access and how to request access. Specifically, the Cures Act requires pharmaceutical companies or distributors to have publicly accessible expanded access policies for drugs treating serious or life-threatening conditions. Expanded access, also known as compassionate use, is a regulatory pathway in which patients may gain access to an investigational therapy outside the context of participation in clinical trials.
The following is Woolsey’s expanded access policy for investigational drugs that are intended to treat serious and life-threatening conditions.
Expanded Access Policy
Woolsey believes that, given the early stage of development of its products, its investigational drugs should be studied in patients as part of controlled clinical trials designed to obtain data on safety and efficacy that may be used to support approval of the product and subsequent wider accessibility to patients. We encourage patients to speak with their physicians and to participate in the available clinical trials. At this time, Woolsey will not provide investigational drug outside of clinical studies and will reevaluate when sufficient preliminary safety and efficacy information has been obtained in clinical trials, typically following Phase 2 investigations.
If you have any questions about our investigational products, please contact Woolsey via email at: firstname.lastname@example.org.
Licensed healthcare providers may request additional information about Woolsey’s clinical trials or expanded access policy via email at: email@example.com.
Woolsey is not currently making its investigational products available on an expanded access basis anywhere in the world. In the event that Woolsey decides to consider making its investigational products available through expanded access programs, requests for expanded access must come from a treating physician.
For Additional Information
For more information on Woolsey’s clinical trials, search “Woolsey” at clinicaltrials.gov.
Additional information on Expanded Access may be obtained by visiting the U.S. Food and Drug Administration at: Expanded Access: Information for Physicians.