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Jae Myung Kim

As seen in: IEEE, MDPI, Lexology
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Articles

CRLs made public: What FDA’s new policy means for the drug industry

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By Jae Myung Kim, Christopher M. Mikson, Perham Gorji, Christine Lentz
| Lexology Verified
The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to increase transparency. The published records were FDA letters originally issued following reviews of new drug applications (NDAs) and biologics license applications (BLAs) that were subsequently approved between 2020 and 2024.
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Q&A: the promotion and sale of pharmaceuticals and medical devices in USA

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By Jae Myung Kim
| Lexology Verified
Advertising and promotion Regulation Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising? The Food and Drug Administration (FDA) has responsibility for regulating the labelling of drugs and devices, as well as the advertising of prescription drugs and restricted devices.
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Multi-Session Electrocardiogram-Electromyogram Database for User Recognition

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By Yeong-Hyeon Byeon, Jin Kim, Cheol Ho Song, Jae Myung Kim
| MDPI
All articles published by MDPI are made immediately available worldwide under an open access license. No special permission is required to reuse all or part of the article published by MDPI, including figures and tables. For articles published under an open access Creative Common CC BY license, any part of the article may be reused without permission provided that the original article is clearly cited. For more information, please refer to https://www.mdpi.com/openaccess.
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