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AI Legislation: The Statewide Spotlight - Regulatory Oversight Podcast
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Solicitors General Insights: A Deep Dive With Mississippi and Tennessee Solicitors General — Regulatory Oversight Podcast
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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more
McDermott’s cross-functional team of life sciences professionals present the inaugural Chicago-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies....more
McDermott’s cross-functional team of life sciences professionals present the second annual Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject...more
On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more