Sean Baird

Sean Baird

Holland & Knight LLP

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FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

7/10/2014 - DQSA Drug Compounding FDA Pharmaceutical Prescription Drugs

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

6/12/2014 - 340B Affordable Care Act Drug Manufacturers Healthcare HRSA Pharmaceutical PHRMA Prescription Drugs

CMS Suggests Significant Changes to Medicare Part D and Medicare Advantage Prescription Drug Plans

The Centers for Medicare and Medicaid Services, CMS, recently issued a Proposed Rule that would initiate important changes to prescription drug plans under Medicare Part D and Medicare Advantage. Comments can be submitted...more

1/23/2014 - CMS Healthcare Healthcare Reform Medicare Medicare Part D Prescription Drug Coverage Prescription Drugs

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