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Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Sheppard Mullin Richter & Hampton LLP on

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Katten Muchin Rosenman LLP

FDA Reduces Regulatory Uncertainty with New Finalized Rule Defining "Biological Product" under BPCIA to Include Insulin and Other...

Katten Muchin Rosenman LLP on

Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more

McDonnell Boehnen Hulbert & Berghoff LLP

Beyond Patents - FDA Regulatory Approval of Medical Devices and the Software Precertification Program

McDonnell Boehnen Hulbert & Berghoff LLP on

Artificial Intelligence (AI) and Machine Learning (ML) are poised to revolutionize the field of healthcare. For example, researchers are leveraging deep learning methods to find new ways to efficiently diagnose and treat...more

Mintz - Health Care Viewpoints

Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation

Mintz - Health Care Viewpoints on

Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Summer 2017

Wilson Sonsini Goodrich & Rosati on

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

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