December 15, 2017 / 4:26 PM / 6 months ago

BRIEF-US FDA Chief Spells Out Agency's Efforts on Targeted Therapies

Dec 15 (Reuters) - U.S. FOOD AND DRUG ADMINISTRATION:

* STATEMENT FROM U.S. FDA COMMISSIONER SCOTT GOTTLIEB ON NEW FDA EFFORTS TO SUPPORT MORE EFFICIENT DEVELOPMENT OF TARGETED THERAPIES

* FDA COMMISSIONER GOTTLIEB - ISSUING 2 DRAFT GUIDANCES FOR MEDICAL DEVELOPERS CLARIFYING FDA’S RECOMMENDATIONS FOR DEVELOPMENT OF INDIVIDUALIZED THERAPIES

* FDA COMMISSIONER GOTTLIEB SAYS FIRST DRAFT GUIDANCE PROPOSES APPROACH FOR DRUG DEVELOPERS TO ENROLL PATIENTS BASED ON IDENTIFICATION OF RARE MUTATIONS

* FDA COMMISSIONER GOTTLIEB - SECOND DRAFT GUIDANCE SEEKS TO PROVIDE THOSE RUNNING CLINICAL TRIALS WITH A CLEAR FRAMEWORK TO REFERENCE REGARDING IVD DEVICES

* FDA COMMISSIONER GOTTLIEB - SECOND DRAFT GUIDANCE’S FRAMEWORK IS TO SEE IF AN IVD DEVICE USED IN THERAPEUTIC PRODUCT STUDY MUST UNDERGO ITS OWN FDA REVIEW

* FDA COMMISSIONER GOTTLIEB SAYS FDA ALSO CONSIDERING WAYS TO STREAMLINE REVIEW OF ONCOLOGY THERAPEUTIC PRODUCTS AND THE IVDS USED WITH THEM Source text for Eikon:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below