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Notice of Intent Food and Drug Administration (FDA)

Hendershot Cowart P.C.

What Is OSHA's Definition Of A “Willful” Work Safety Violation?

Hendershot Cowart P.C. on

The Occupational Safety and Health Administration (OSHA) defines a "willful" violation as one where the employer either knowingly failed to comply with a legal requirement or acted with plain indifference to employee safety....more

Mintz - Health Care Viewpoints

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more

Fenwick & West LLP

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Fenwick & West LLP on

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

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