FDA Adds 70+ Class I Medical Devices to List of Those Exempt from 510(k) Requirements

The notice published in the Federal Register on April 7, 2017 is summarized as follows: “The Food and Drug Administration (FDA or Agency) has identified a list of class I devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures…

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Download our latest paper: What is a Biosimilar and How Does it Differ Compared to Drug Development?

Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generics are to brand-name drugs. However, there are major differences between the…

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What is a Biosimilar and How Does it Differ Compared to Drug Development?

Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generic drugs are to brand-name drugs. However, there are major differences between…

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Sanders, Cummings Announce Congressional Investigation into Marathon’s Recently Approved Emflaza® (deflazacort)

On February 9, FDA announced approval of a new drug to treat Duchenne muscular dystrophy. In fact, NDAs 208684 and 20685 (oral tablets 6, 18, 30, and 36 mg and oral suspension 22.75 mg/mL), both orphan drugs, were approved that day.  However, by February 13, Reuters reported that “Marathon pauses Duchenne drug launch amid price outcry”.…

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