March 22, 2020 / 9:02 PM / 13 days ago

BRIEF-FDA Provides Update On Patient Access To Certain Rems Drugs During Covid-19 Public Health Emergency

March 22 (Reuters) - U.S. FDA:

* FDA PROVIDES UPDATE ON PATIENT ACCESS TO CERTAIN REMS DRUGS DURING COVID-19 PUBLIC HEALTH EMERGENCY

* FDA- ISSUED NEW GUIDANCE TO SPONSORS, HEALTHCARE PROVIDERS REGARDING CERTAIN RISK EVALUATION AND MITIGATION STRATEGY REQUIRED TESTING DURING THIS TIME

* FDA- DOES NOT INTEND TO TAKE ACTION AGAINST SPONSORS IN PUBLIC HEALTH EMERGENCY FOR NOT ADHERING TO REMS NEEDS FOR SOME LAB TESTING OR IMAGING STUDIES

* FDA - MAY REQUIRE REMS FOR CERTAIN DRUGS IF AGENCY DETERMINES THAT IT IS NECESSARY TO ENSURE THAT BENEFITS OF DRUG OUTWEIGH ITS RISKS

* FDA- POLICY OUTLINED IN GUIDANCE WILL BE IN EFFECT FOR DURATION OF PUBLIC HEALTH EMERGENCY 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