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Regulatory Agenda › Food and Drug Administration (FDA) › Pharmaceutical Patents

McDonnell Boehnen Hulbert & Berghoff LLP

Five Years Ago Today . . .

McDonnell Boehnen Hulbert & Berghoff LLP on

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear."  At...more

Skadden, Arps, Slate, Meagher & Flom LLP

The FTC Challenges Companies’ Allegedly Improper Orange Book Patent Listings

Skadden, Arps, Slate, Meagher & Flom LLP on

The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

Jones Day on

Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

Proskauer - The Patent Playbook on

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

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 2

Hogan Lovells on

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

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Hogan Lovells

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents,...

Hogan Lovells on

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

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