News & Analysis as of

Medical Devices Pharmaceutical Industry Biosimilars

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Section 337 Actions at the ITC: another forum for pharma and biosimilars litigation?

by Goodwin on

With the growing volume of biosimilar and pharma litigation in district courts and before the PTAB, the U.S. International Trade Commission may emerge as another forum for patent holders against imported biosimilars. Section...more

Washington Healthcare Update

by McGuireWoods LLP on

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

Health Care Reform: Key Legislative Changes Impacting the Pharmaceutical, Biotechnology, and Medical Device Industries

by Ropes & Gray LLP on

Last week, Congress adopted comprehensive health care reform through the passage of the Patient Protection and Affordable Health Care Act (H.R. 3590) (signed into law on March 23) and the Health Care and Education...more

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