Fast track to a

• What is a fast track program?

  The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life- threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products).

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• What is a fast track drug?

  The term drug refers to the combination of two or more drugs if the combination is the subject of the fast track designation or request. Where appropriate, FDA may grant designation to the development of a new use of an approved drug.

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• Who does fast track rely on?

  Fast Track relies upon AOs, Program Information System Owners (ISOs), Program Managers (PMs), Program Information System Security Managers (ISSMs), and Wing Information Assurance staffs. The ATO process carries a

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• How do I request a fast track designation?

  request for fast track designation should be submitted as an amendment to the sponsor's IND in triplicate with Form FDA 1571 attached or, if the request is simultaneous with submission of the original IND, should accompany the IND.

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• Guidance for Industry - U.S. Food and Drug Administration

  fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation (referred to in this guidance as the Agency’s expedited programs).

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• [PDF File]Fast Track ATO - AF

  https://info.5y1.org/fast-track-to-a_1_583d34.html

  Version 20 Jul 2021 #5 in the Blue Cyber Education Series Distribution Statement A: Approved for public release. Distribution is unlimited. Case Number: AFRL-2021-2421, 26 Jul 2021. The Fast Track Authorization to Operate (ATO) allows the AO to make an authorization decision based on the review of a Cybersecurity Baseline,

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• SOPP 8216:Fast Track Programs: Designation and Management

  This Standard Operating Policy and Procedure (SOPP) serves as a guide for Center for Biologics Evaluation and Research (CBER) staff for processing and reviewing requests for fast track...

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• [PDF File]Fast-Track Targets 90-90-90 95-95-95 ZERO - UNAIDS

  https://info.5y1.org/fast-track-to-a_1_563b57.html

  The Fast-Track approach is an agenda for quickening the pace of implementation, focus and change at the global, regional, country, province, district and city levels. It involves setting ambitious targets and accelerating the delivery of high-impact HIV prevention and treatment services.

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• [PDF File]Guidance for Industry - NCL Innovations

  https://info.5y1.org/fast-track-to-a_1_2c1c7b.html

  Fast track programs should be distinguished from expanded access programs for investigational drugs such as the treatment investigational new drug (IND) regulations (52 FR 19466, May 22, 1987; codified as 21 CFR 312.34). Fast track is intended to facilitate development and expedite

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• [PDF File]FAST TRACK - FAA ADHD EVALUATION - GENERAL INFORMATION

  https://info.5y1.org/fast-track-to-a_1_c7f220.html

  FAST TRACK - FAA ADHD EVALUATION - GENERAL INFORMATION (Updated 08/30/2023) If you are a PILOT or ATCS with a history of ADHD or taking ADHD Medications: 1. See your treating physician and get healthy. 2. Do not fly, in accordance with 14 CFR 61.53, until you have an Authorization from the FAA.

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