2015 Individual Patients Vaccination 
FDA Law Blog
AUGUST 21, 2023
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. A recent state law failure-to-warn case in the SDNY makes that very point. But we digress.
FDA Law Blog
SEPTEMBER 14, 2021
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. 8126 with a lower MFP.
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