By Ramsey Baghdadi
The Food & Drug Administration's top priority for the re-review of GlaxoSmithKline's diabetes drug Avandia is to deliver a credible...
FDA's Brilliant Management of Avandia Re-Review Provides Flexibility on Final Decision
Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.
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The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
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Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
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Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
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The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.
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Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
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Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
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Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.