Image description

FDA unveils efforts to speed complex generic approval

In a post on the Food and Drug Administration’s blog, commissioner Dr. Scott Gottlieb noted that in many instances complex drugs — which include drugs with complex active ingredients and complex drug-device combination products — do not have generic competitors for various reasons.

Image description

NCPA-commissioned study: DIR fees could cost CMS $3.4B in next 10 years

The report evaluates the impact of the Improving Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, which has been introduced in both the Senate and House of Representatives and prohibits retroactive pharmacy payment reductions as claims without any defect, impropriety or fraud in Medicare Part D.

Image description

FDA takes aim at online pharmacies

The Food and Drug Administration worked with international regulatory and law enforcement agencies take action against some 500 websites selling illegal and unapproved versions of such prescription drugs directly to American patients.