The proposed rule undermines the 'sameness' requirement in Hatch-Waxman and will result in situations where multiple FDA-approved, therapeutically equivalent products will have different safety-related labeling.
Pitts criticizes a proposed FDA rule affecting generic drug labeling.
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One in five trauma deaths may be preventable or, in other words, about 30,000 people might be saved every year.
Parity means that insurers need to treat copayments, treatment limits, prior authorization for mental health, substance use disorder the same way they treat for physical health care.
So, moving forward, the committee welcomes feedback on how we can improve care for children with medical complexity without disrupting the successful approaches already in place.
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