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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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Podcast Episode: Febrile Seizures

PEMBlog

Common variants associated with general and MMR vaccine-related febrile seizures. 2008 Jul 15;71(3):170-6. Epub 2008 Jun 4. Vaccines don’t cause autism, but they might cause febrile seizures. The absolute risk is small, and genetic susceptibility likely plays a role in seizures after vaccines. PMID: 18525033.

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