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Tag Archives: Regulatory
With the Election Decided, It's Full Speed Ahead on ObamaCare
by Tom Norton
With the Presidential election decided and President Obama the clear winner, it’s time for Pharma to get down to business on the implementation of ObamaCare. Here are some of the key actions to anticipate between now and January 1, 2013.
Posted in FDA, Legal, Regulatory, Strategy, healthcare Also tagged Affordable Care Act, HHS, Medicare, Obamacare, Presidential election, US election 3 Comments
Budget policies jeopardize FDA funding, user fees
Budget policies jeopardize FDA funding, user fees
Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year. FDA, [...]
Posted in FDA, Guest Blog, Regulatory Also tagged CR, FDA, FDA safety and innovation act, GDUFA, Medicare, Washington Leave a comment
Bristol-Myers Squibb's Summertime Blues
The sun was shining, savory scents were floating out from the grill, the lemonade was mixed and the table was set. But then dark clouds blew in and settled overhead. Bristol-Myers Squibb’s (BMS) picnic got rained out this summer.
One element of the rain out was forecasted long ago; Plavix, the multibillion dollar [...]
Posted in Advertising, Biotech, Deals, FDA, Legal, Marketing, R&D, Regulatory, Safety, Sales, Strategy, compliance, pricing Also tagged Bristol-Meyers Squibb, FDA, Office of Prescription Drug Promotion, OPDP, Untitled Letter Leave a comment
US v. Caronia: What Constitutes 'Truthful' Speech?