ASCA 2024 Performance Update: Can ASCA Improve Submission Predictability?
FDA Law Blog
by Kurt R. Karst
2d ago
By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert ..read more
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Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025
FDA Law Blog
by Kurt R. Karst
3d ago
By Sarah Wicks & Dara Katcher Levy ..read more
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Court Rejects Challenge to DEA ALJ Hearing Authority Over Removal Power
FDA Law Blog
by Kurt R. Karst
5d ago
By Andrew J. Hull ..read more
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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind
FDA Law Blog
by Kurt R. Karst
6d ago
By Sarah Wicks & Anne K. Walsh ..read more
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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs
FDA Law Blog
by Kurt R. Karst
1w ago
By Kurt R. Karst ..read more
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Every Claim You Make, Every Step You Take…CVM Will Be Watching You
FDA Law Blog
by Kurt R. Karst
1w ago
By Sara W. Koblitz & Dara Katcher Levy ..read more
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ACI’s 23rd Advanced Summit on Life Sciences Patents
FDA Law Blog
by Hyman Phelps McNamara
1w ago
Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institute’s 23rd Advanced Summit on Life Sciences Patents, which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY.  In a year of major change and outstanding questions, growing scrutiny on patent protection and drug pricing, and uncertainty around global price control measures and the Inflation Reduction Act, understanding the implications of new leadership and emerging mandates is critical. Gain ..read more
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FDA’s Vape Ban Hits the Right Note: Supreme Court Says “Let It Be”
FDA Law Blog
by Kurt R. Karst
1w ago
By Andrew J. Hull & David B. Clissold & Sophia R. Gaulkin & Esther Petrikovsky ..read more
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Hyman, Phelps & McNamara Enters its 45th Year Continuing to Expand its Capabilities to Meet Client Needs
FDA Law Blog
by Hyman Phelps McNamara
1w ago
Hyman, Phelps & McNamara (HPM) marks its 45th Anniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firm’s FDA and DEA practices. Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDA’s Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. Dr. Lowy previously served as the Deputy Director, Division of Anesthesiology, Addition and Pain Medicine and the Associate Director for Regulatory Science, Office of Drug Evaluation 1, CDER. Andrew H ..read more
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While FDA Suffers Staffing Cuts, Nondelegation Case in SCOTUS Is Latest Legal Challenge to Curb Agency Powers
FDA Law Blog
by Kurt R. Karst
1w ago
By John W.M. Claud & JP Ellison ..read more
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