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FDA-Approved Labeling: Is Enough Enough?

FDA Law

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. But we digress. Just like it was over a decade ago in Pliva v.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed. 8126 with a lower MFP.