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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more