ACI’s 10th Anniversary Paragraph IV Disputes Master Symposium
The American Conference Institute (“ACI”) is holding its 10th Anniversary Paragraph IV Disputes Master Symposium from October 15-16, 2024, at the Hyatt Regency McCormick Place in Chicago, Illinois....
View ArticleWound Products, Antimicrobial Resistance, and Commercial Speech: FDA’s...
By Jennifer D. Newberger —In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these...
View ArticleDraft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for...
By John W.M. Claud —There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that...
View ArticleThe Summit for Women Leaders in Life Sciences Law
By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert —The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport...
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Another Attack on the Carve-Out: Novartis Seeks a TRO Enjoining ENTRESTO Generic
By Sara W. Koblitz —Increasingly the subject of induced infringement litigation, the viability of the carve-out has been questioned for several years now. But recently, a new challenge was filed in...
View ArticleFederal Marijuana Rescheduling: States Get Ready
By Larry K. Houck —States better get ready, Rescheduling may be coming, You may need to make changes, You may need to do more, Than just get on board. (With apologies to Curtis Mayfield) By the close...
View ArticleIt’s a Cruel Summer – Two New OPDP Untitled Letters
By Sarah Wicks & Dara Katcher Levy —FDA’s Office of Prescription Drug Promotion (OPDP) has issued two new Untitled Letters this summer after 5 months without any letter activity. The letters are...
View ArticleEvery Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase...
By Sara W. Koblitz —In the world of patent term extensions, every day considered part of the regulatory review period is important, as that day—either in whole or in part—gets added back to the patent...
View ArticleCMS Issues Proposed Rule on the Medicare Part B and Part D Inflation Rebate...
By Alan M. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui & Sophia R. Gaulkin —Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security...
View ArticleLong Time Passing: Where Have All the De Novo Decision Summaries Gone?
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs —In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to...
View ArticleDEA To Announce Hearing on Proposed Marijuana Rescheduling
By Larry K. Houck —Who says nothing happens in Washington, D.C., in August? The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on...
View ArticleACI’s 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman...
The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. This virtual three-week...
View ArticleDecades Later, Congress Continues Debating the Preserve Access to Affordable...
By Kurt R. Karst & Michael D. Shumsky —As readers of this blog know (see, e.g., here), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two...
View ArticleRules? Where We’re Going, We Don’t Need Rules: FDA Goes Back to the Future...
By Kurt R. Karst —Tell me doctor, where are we going this time? Is this the 90s, or 2025? Apologies to both Robert Zemeckis, who directed the 1985 classic “Back to the Future,” and to Huey Lewis and...
View ArticleWhere Have All the De Novo Summaries Gone: An Update
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs —Thank you to readers of this blog. We received incredible feedback on our August 19 post analyzing the number of...
View ArticleSixteen HP&M Attorneys Recognized by Best Lawyers® in 2025 in America
Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce that 16 of the Firm’s attorneys have been selected to the 2025 edition of The Best Lawyers in America®. Founding Director Paul M....
View ArticleRevised Final Guidance on Nitrosamines Offers New Recommendations for...
By John W.M. Claud —Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug...
View ArticleDays Go By* – Particularly When Responding to an FDA Inspection
By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Anne K. Walsh —While we hope readers of the Blog, as our clients...
View ArticleThe Greatest Trick the Devil Ever Pulled was Convincing the World He Didn’t...
By Kurt R. Karst —“Inter Partes Review” and “Section 101” are not terms you typically run into on this all-things-FDA blog, but we have talked about such patent-related issues before (here and here),...
View ArticleFDA Publishes Its Draft Strategy Document on Innovative Manufacturing...
By Mark I. Schwartz —FDA recently published a Federal Register (FR) Notice [Docket No. FDA-2024-N-3945] announcing the publication of a draft strategy document, for public comment, outlining specific...
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