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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, for years, has been concerned with overwarning.

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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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