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This profile was last updated on 2/18/2016 and contains contributions from the  Zoominfo Community.

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Wrong Martha Donoghue?

Martha Donoghue

Pediatric Solid Tumors Scientific Liaison

Food and Drug Administration

HQ Phone:  (301) 827-6500

Direct Phone: (301) ***-****direct phone

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I agree to the Terms of Service and Privacy Policy. I understand that I will receive a subscription to ZoomInfo Community Edition at no charge in exchange for downloading and installing the ZoomInfo Contact Contributor utility which, among other features, involves sharing my business contacts as well as headers and signature blocks from emails that I receive.

Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland,20852

United States

Company Description

China's Food and Drug Administration (SFDA) is now offering a reward of about 50,000 US dollars for relevant information on counterfeit drug production. The bounty aims to "encourage the public to report illegal activities so as to determine, control and elimi...more

Web References(3 Total References)


CureSearch Catapult 2016 | Healthspottr

www.healthspottr.com [cached]

Dr. Martha Donoghue, Pediatric Solid Tumors Scientific Liaison, United States Food and Drug Administration
Martha Donoghue Pediatric Solid Tumors Scientific Liaison, FDA


blog.sermo.com

- Martha Donoghue, Clinical reviewer, hematology and oncology products, US Food and Drug Administration


www.ascopost.com

By Paul Kluetz, MD, and Martha Donoghue, MD
In this article, FDA reviewers Dr. Kluetz and Dr. Donoghue, address questions relating to the role of expedited programs for the development of cancer therapies. Dr. Donoghue: Both Fast Track and Breakthrough Therapy designation are designed to speed up drug development, but the level of evidence required to qualify, and the degree of FDA interaction provided by these designations differ. Dr. Donoghue: In essence, we endeavor to confer Breakthrough Therapy designation to investigational therapies that we think have the potential to be transformative. Dr. Donoghue: Both designations apply to a specific use for which a therapy is being studied, so a therapy being developed for multiple indications may have Breakthrough Therapy or Fast Track designation for one or more potential indications, but not for others. Dr. Donoghue: Actually, the process is pretty efficient, as long as companies provide sufficient information to support the Breakthrough Therapy designation request in a format that is well organized. Dr. Donoghue: Pitfalls can occur during the course of drug development and NDA or BLA review, particularly when development occurs on a compressed timeline. Dr. Donoghue: I hope that we have shed some light on the four programs that sponsors and the FDA have at their disposal to expedite drug development for serious conditions. Disclosure: Dr. Kluetz and Dr. Donoghue reported no potential conflicts of interest.


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