jueves, 3 de agosto de 2017

New Expanded Access Navigator tool | Zika therapeutics workshop in September

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August 3, 2017  |  FDA Medical Countermeasures Initiative Update

Expanded Access Navigator helps patients, caregivers, and physicians

New Expanded Access tool for patients, caregivers, and physicians 

Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy and who seek access to potentially life-saving investigational drugs will have another option to guide them through the process, thanks to the launch of a new online tool called the Expanded Access Navigator
The Expanded Access Navigator helps educate patients and physicians about the process. Most of what they need to seek expanded access is now available in this single online location, including a directory where companies can submit public links to their expanded access policies, criteria used by companies to determine whether to make a drug available through expanded access, and contact information.
The development of the Navigator was a team effort led by the Reagan-Udall Foundation in collaboration with patient advocacy groups, the pharmaceutical industry, FDA, and others in the Federal government.
Related information

EUA Updates

New Zika diagnostic EUA:
  • August 2, 2017: TaqPath Zika Virus Kit (Thermo Fisher Scientific) - more info
Zika diagnostic EUA amendment:
  • July 31, 2017: Zika MAC-ELISA (CDC) - more info
Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.
Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated July 24, 2017.
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