HighPoint Blog

On July 18, 2018, the FDA published its guidance for biosimilars, “Labeling for Biosimilar Products.” This guidance provides an overview of the FDA’s recommendations for biosimilar labeling, so that prescribers can make informed decisions. The FDA states the intent of the guidance is to help manufacturers “develop draft labeling for proposed biosimilar products for submission in an application...

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On January 21, 2016, CMS released an advance-print copy of the long-awaited final rule on the Medicaid Drug Rebate Program (MDRP). The final rule implements various statutory amendments, revises the calculation of Average Manufacturer Price (AMP), makes certain changes to the determination of Best Price and addresses other issues relating to Medicaid price reporting and reimbursement. The...

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