Commercial Operations

OMB Sources Say Sequestered User Fees Cleared Under Omnibus Bill

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

Year in Review: Global Transparency Initiatives Dominate Busy 2013

The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead. Read More

Teva Chooses Erez Vigodman as CEO

Teva Pharmaceuticals has chosen an agro-chemicals expert as its new CEO. Former Makhteshim Agan Industries (MAI) chief Erez Vigodman takes Teva’s helm Feb. 11, Teva said Thursday. Read More