Abbvie

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Expanded Access Listings

Expanded Access to Telisotuzumab Vedotin

Conditions
Non-small Cell Lung Cancer (NSCLC)

This is an expanded access program (EAP) for eligible participants. This program isdesigned to provide access to Telisotuzumab vedotin prior to approval by the localregulatory agency. Availability will depend on territory eligibility. A medical doctormust decide whether the potential benefit outweighs the risk of receiving aninvestigational therapy based on the individual patient's medical history and programeligibility criteria.

Winners of 2019 Innovations in Regulatory Science Awards Announced

FDA’s Theresa Mullin, Compassionate Use Advisory Committee, and Cystic Fibrosis Foundation to be Honored with Innovations in Regulatory Science Awards 

Honorees to be recognized on December 11 in Washington, DC

Washington, DC - The Reagan-Udall Foundation for the FDA will present 2019 Innovations in Regulatory Science Awards to Theresa M. Mullin, PhD, of the FDA’s Center for Drug Evaluation and Research; the Compassionate Use Advisory Committee, a collaborative program of Johnson & Johnson and New York University; and the Cystic Fibrosis Foundation.

Announcements

Reagan-Udall Foundation for the FDA invites Nominations for IMEDS Steering Committee

The Reagan-Udall Foundation for the FDA seeks nominations for key positions on its Steering Committee. Comprised of 12 members, the IMEDS Steering Committee provides oversight and guidance on the operation of IMEDS by advising on strategic direction, helping to integrate IMEDS within the research community, and providing input on IMEDS program activities.

Announcements
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