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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. A recent state law failure-to-warn case in the SDNY makes that very point. But we digress.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. The Part B rebate would exclude vaccines as well.