On September 25, 2012, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report entitled “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.”
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Wall Street Journal: FDA Urged to Speed Approval of Drugs
A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.
The President’s Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called “special medical use” approvals.
The FDA Law Blog: White House Releases Major Paper on Propelling Innovation in Drug Development and Recognizes HP&M’s Frank Sasinowski for Contributions