Day: March 24, 2016

The breakthrough therapy designation (BTD) has been lauded as one of the most innovative of regulatory pathways as it modifies the conventional drug development, review and approval processes to speed up availability of new drugs to the patients. Since its implementation in 2012, more than 100 drugs have obtained this designation and already 39 new drugs have … Read more

FDA and CDC took several major steps this month to address abuse of prescription opiates. Opiate abuse is a major healthcare issue and has been termed a “crisis” and an “epidemic”. A detailed action plan was announced by FDA last month, one of the first major actions by the new FDA Commissioner.  Abuse or Overdose accounts for about … Read more