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
In Washington: In a statement on Monday, Food and Drug Administration (FDA) Commissioner Stephen Hahn and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, responded that it was...more
Earlier this month, two bills intended to promote generic competitiveness by presenting a clearer idea of the patent landscape covering reference products passed the full Senate, albeit with amendments. These laws, if...more
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
Regarding the Trump Administration’s August 6, 2020 “Buy American” Executive Order, which was the subject of a prior client alert, the U.S. Food and Drug Administration (FDA) announced that it published a list of 223 drug and...more
As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more
NEW SENATOR JOINS HEALTH COMMITTEE - Newly sworn-in Sen. Kelly Loeffler, R-Ga., is the newest member of the Senate Health, Education, Labor and Pensions Committee....more
On December 10, 2019, Canada, the United States and Mexico signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada (commonly referred to as the USMCA). The...more
On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994....more
On Monday, December 2, 2019, The Wall Street Journal reported that the Trump administration is considering reducing the 12-year data exclusivity period for biologic drugs set forth in the Biologics Price Competition and...more
Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more generic drugs to market...more
After more than a year of sometimes contentious negotiations, the United States, Mexico, and Canada (the “Parties”) reached an agreement late Sunday night to revise the North American Free Trade Agreement (“NAFTA”)—renaming...more
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more
A tripartite agreement to save NAFTA has been reached. The agreement, reached late last night, provides Congress the necessary 60 days’ notice of the text to approve so that President Pena Nieto of Mexico can sign before he...more
Late on September 30, an agreement (USMCA) was reached between the United States, Mexico and Canada which modernizes the 24 year old North American Free Trade Agreement (NAFTA)....more
The Medicare program is once again looking to reduce payments to 340B hospitals for Part B drugs and biologicals. As part of its proposed payment regulation for hospitals under the Outpatient Prospective Payment System (OPPS)...more
LAWMAKERS COOL TO TRUMP PLAN ON HHS, GOVERNMENT REORGANIZATION - The response from lawmakers on Capitol Hill to the White House plan to reorganize the federal government – including proposed changes to multiple healthcare...more
In the wake of President Trump's decision to withdraw from the Trans-Pacific Partnership, the other countries involved in negotiations (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore,...more
• Congress amended current law to prevent CMS from applying the “MIPS” payment adjustment to separately billed items like drugs and biologics, which will drastically reduce the total amount of payment adjustments to clinical...more
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
President Donald J. Trump has now been in office for just over one hundred days. Observers have been quick to mark this milestone and assess the new administration’s performance, especially on headline-grabbing issues like...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
In public debates over the Affordable Care Act (ACA), also known as Obamacare, biosimilars are rarely, if ever, mentioned. But the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA), was in...more
As previously posted, President Trump has stated that he planned to issue a notification of intent to withdraw from the Trans-Pacific Partnership (TPP), which is a proposed trade agreement between several pacific countries...more