Newsletter - March 24, 2016
Opiate Regulation Gets a Major Makeover
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 11000 deaths and about 420000 emergency room visits every year in the US. There are 18 opioid drugs and about 60 products in the US market. Read More..
Breakthrough Designation Speeds Up Approval but Strains FDA’s Resources
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 been approved under this pathway, mostly for treatment of cancer. Read More..
Opiate Regulation Gets a Major Makeover
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 11000 deaths and about 420000 emergency room visits every year in the US. There are 18 opioid drugs and about 60 products in the US market. Read More..
Breakthrough Designation Speeds Up Approval but Strains FDA’s Resources
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 been approved under this pathway, mostly for treatment of cancer. Read More..
