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Health Reform in 2013: The Sprint to the Starting Line
The Affordable Care Act has nearly died at least three times since the final bill took shape in 2010; with the re-election of Barack Obama, it is all systems go. But remember, the race to implement the program by 2014 is only the beginning, not the end, of health care reform.
Appeals Court Reaffirms DNA Patents; Myriad Case May Be Headed To Supreme Court
A Federal Circuit panel again rules that Myriad Genetics’ patents covering BRCA genes isolated from the body are patent-eligible; the ACLU may request review by the full court or file a petition with the Supreme Court.
PDUFA V Agreement Set In Four Areas, But Broad FDA/Industry Talks Continue
FDA and industry have reached agreement on four issues in the Prescription Drug User Fee Act reauthorization, including adjustments to risk-benefit policy and creation of a meta-analysis team.