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Regulatory Agenda Biologics Biosimilars

Smart & Biggar

Update on biosimilars in Canada – March 2024

Smart & Biggar on

In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Proskauer - Life Sciences

President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

Epstein Becker & Green

FDA and FTC Join Forces to Promote Biosimilars

Epstein Becker & Green on

The U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) (collectively, the “Agencies”) have a long history of teaming up to ensure that advertising and other promotional communications for...more

Hogan Lovells

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

Hogan Lovells on

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more

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