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Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight [PODCAST]

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.

 

 

Copyright 2022 K & L GatesNational Law Review, Volume XII, Number 269
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About this Author

 Rebecca M. Schaefer healthcare & Transactional Attorney K & L Gates Law Firm North Carolina
Partner

Rebecca Schaefer is a partner at the firm’s Research Triangle Park office. She is a member of the health care practice group, focusing her practice on healthcare regulatory and transactional matters. Ms. Schaefer has specialized knowledge of issues affecting academic medical centers, including those related to faculty practices, clinical research, mission support, governance and privacy. She provides counseling to health systems, physician practice groups and in-house pharmacies related to strategic affiliations, joint ventures, and compliance matters.  

Prior to...

919.466.1111
Michael Hinckle, FDA regulatory and pharmaceutical pricing attorney, KL Gates, Law Firm
Partner

Mr. Hinckle’s practice focuses on counseling corporations and individuals on all aspects of FDA regulatory and pharmaceutical pricing matters.  His primary efforts are in the area of pharmaceutical, biologic, and medical device regulation as well as related corporate transactional activities.  His experience includes serving as in-house General Counsel for an international pharmaceutical corporation with responsibilities for all legal activities, regulatory affairs, quality assurance, corporate compliance and litigation oversight.  Mr. Hinckle’s experience also includes...

919-466-1115
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