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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. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

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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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