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Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More
With patents expiring on several blockbuster drugs in 2014, generic competition and cost-containment policies around the globe will hold brand pharma’s revenue growth at bay this year. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More
Drugmakers that promote their products in real time on blogs, social media sites and other interactive websites need to submit those sites to the FDA for review as promotions. Read More
When creating product labels for the Canadian market, drugmakers’ claims should be based on the product’s own merits rather than on how it compares to other products, Health Canada says. Read More
Congressional lawmakers will work to eliminate the Physician Payment Sunshine Act requirement that drugmakers disclose gifts of medical journals and textbooks to physicians after the Centers for Medicare & Medicaid Services (CMS) refused their request to reverse the policy. Read More
Lawmakers and the White House Office of Management and Budget (OMB) have agreed on language to include in an omnibus fiscal 2014 appropriations bill that will allow the FDA to retrieve $85 million in user fees sequestered last year. Congress had set a deadline of Jan. 15 for voting on the bill; however, lawmakers signaled Friday they may need more time for debate. Read More
Government prosecutors are asking Aegerion Pharmaceuticals to hand over documents tied to sales and marketing of its cholesterol drug Juxtapid, putting the company in the spotlight for compliance concerns for a second time. Read More
Santaris Pharma and GlaxoSmithKline have signed a deal giving GSK access to Santaris’ locked nucleic acid technology in order to develop RNA-targeted medicines. Read More