FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Drug & Device Law

MARCH 19, 2024

The manufacturer argued that it did not purposefully avail itself of the privilege of conducting business in Rhode Island because it manufactured a global product that it delivered to distributors who were responsible for marketing and selling the clips in the United States. 3d 679 (D.N.J. 2021) (“ TBI ”).

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Drug & Device Law

JANUARY 25, 2024

It is a simple fact that product liability plaintiffs almost always prefer state court and product liability defendants almost always prefer federal court. Other realities are that California has some of the most pro-plaintiff, pro-product liability laws around and that federal courts in California are very tough on removal.

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Drug & Device Law

JANUARY 15, 2024

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

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Drug & Device Law

JULY 26, 2023

From a bottom-line perspective, the most significant result was that evidence of the product’s 510(k) clearance was improperly excluded, requiring vacation of the verdict and a new trial. So do a number of other jurisdictions, including Pennsylvania in prescription medical product cases. labeling regulations. at *14-15. [I]n

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