News & Analysis as of September 25, 2024

Biologics › Obama Administration

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Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

Mintz - Health Care Viewpoints on 5/23/2017

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...more

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

McDonnell Boehnen Hulbert & Berghoff LLP on 6/30/2016

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

What May Be the IP Provisions of the Trans Pacific Partnership Agreement

McDonnell Boehnen Hulbert & Berghoff LLP on 10/16/2015

The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible: they have kept the details of the draft agreement secret from the press and interested parties in the United States,...more

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Biologics › Obama Administration

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

What May Be the IP Provisions of the Trans Pacific Partnership Agreement

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