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Statutory Interpretation › Prescription Drugs › Chevron Deference

McDermott Will & Emery

Loper Bright and the 340B Statute

McDermott Will & Emery on

In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

Venable LLP on

Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more

Bricker Graydon LLP

Supreme Court makes certiorari determinations on two Medicare-related cases

Bricker Graydon LLP on

A number of health care related cases have come before the United States Supreme Court this session, including two cases on topics we have previously reported on: Medicare’s site-neutral payment policy for off-campus...more

Troutman Pepper

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

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