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…of the Center for Devices and Radiological Health, stated that “[u]sing complex medical devices at home carries unique challenges … Caregivers may lack sufficient training, product instructions may be inadequate…
By William T. Koustas — The FDA has announced that it will require all drugs known as Erythropoiesis-Stimulating Agents (“ESAs”) to have a Risk Evaluation and Mitigation Strategy (“REMS”). At…
By Jeffrey N. Wasserstein Your faithful bloggers at FDA Law Blog are, as you might expect, big fans of social media tools. After all, we blog, we tweet, and we…
…social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable? (3) What parameters should apply to the posting…
…review of a small business certification request within 60 calendar days of receipt. If granted, the company can enjoy the benefits for that fiscal year alone, which runs from October…