Patient Pushback On FDA Reform: Efficacy Matters
If there is going to be an effort to roll-back efficacy standards for drug approvals, patient organizations are likely to join in – in defense of the status quo.
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Biogen Spinraza Approval: The Perfect Antidote To Sarepta Headlines?
Approval of Biogen/Ionis’ Spinraza gives the drug development community a successful, collaborative model for a rapid pathway to full approval for a rare disease therapy; it also provides a timely, compelling rebuttal to claims that US FDA’s drug review operations are in dire need of reform.
Possible Trump FDA Commish Candidate Favors (Much) Lighter Touch
Jim O'Neill, a Silicon Valley investment manager, would be an unusual choice to head US FDA, not just because he isn’t a physician, but because he’s favored substantially reducing FDA's role in assessing product effectiveness. While some experts are highly skeptical about O'Neill, who worked at HHS in the Bush administration, others suggest he could champion much-needed change at the agency.
The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA
Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.