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The Biden Administration's Push for Transparency in AI Technology
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Consumer Finance Monitor Podcast Episode: What the Biden Administration’s “Junk Fees” Initiative Means for the Consumer Financial Services Industry: A Look at the Fees Under Attack, Part II
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Consumer Finance Monitor Podcast Episode: The U.S. Supreme Court’s Decision Invalidating the Biden Administration’s Student Loan Forgiveness Plan and its Potential Legal Repercussions
Consumer Finance Monitor Podcast Episode: A Close Look at the Impact of Antitrust Laws on the Consumer Financial Services Industry
DE Under 3: President Biden Issued "Modernizing Regulatory Review" Executive Order
Business Better Podcast Episode: An Update on Environmental Justice Under the Biden Administration
#WorkforceWednesday: FTC Proposes Ban on Non-Competes - Employment Law This Week® - Spilling Secrets Podcast
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Latest News...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
President Biden, in July 2021, issued an Executive Order (“E.O.”) observing that “too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and...more
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
The USPTO will be hosting a “public listening session” on January 19, 2023, focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's Executive Order on “Promoting Competition in the American...more
On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more
Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action to...more
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more
On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of...more
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States...more
On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more
Also Codifies FDA's Longstanding "Active Moiety" Approach for New Chemical Entity Exclusivity - In April 2021, President Biden signed two bipartisan bills that aim to promote drug competition and to reduce prescription...more
In Washington: The Biden administration announced Wednesday that it supports a proposal to waive international patent protections for COVID-19 vaccines. U.S. Trade Representative Katherine Tai said in a statement that the...more