Insights on Drugs & Biologics

By now, almost everyone is aware of the dire situation that exists in the United States for testing patients with the Coronavirus.

On October 18, Arent Fox’s New York office will host a one-of-a-kind event on behalf of the New York State Bar Association that focuses on the intersection of FDA and sports law.

WASHINGTON — Fifty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2020.

While he did not use a hemp pen like the one used by Senate Majority Leader Mitch McConnell (R-KY) to sign the conference report, President Trump signed into law the 2018 farm bill that includes a provision that legalizes hemp. Specifically, the provision would remove hemp from the federal list of c

Arent Fox FDA Associate Emily Leongini will present at CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities.

NEW YORK – Earlier this year, Yeshiva University’s Katz Graduate Business School introduced a new 36-credit Master of Science in Biotechnology Management and Entrepreneurship designed to prepare future business leaders in the life sciences to successfully navigate the launching new medical drugs.

President Trump signed into law a bill that expands the Open Payments reporting requirements.

Arent Fox Intellectual Property Partner Alex Spiegler and FDA Associate Emily Leongini will present at the International Bar Association (IBA) 6th Annual World Life Sciences Conference.

Arent Fox Associate Emily Leongini will speak at the Food and Drug Law Institute (FDLI) Annual Conference hosted May 3-4, 2018 in Washington, DC.

Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.

The US Food and Drug Administration recently issued warning letters to four companies.

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative medicine. 

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act.

Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, with a 60-day comment period ending around September 3, 2017.

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency’s rules have been, in the agency’s view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.

National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests.

Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

The White House issued an executive order on January 30, 2017 requiring agencies and executive departments to “identify at least two existing regulations to be repealed” whenever they propose or promulgate a new regulation.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.