Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Drug & Device Law

DECEMBER 21, 2023

Speaking of cold and darkness, it is now time for us to look back upon the results of drug and medical device litigation during 2023 and to select the ten worst decisions of the year. 122 (2023) ( here ). FDA , 78 F.4th We also consider the same court’s equally politicized attack on FDA authority in Apter v. State ex rel.

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Drug & Device Law

JULY 24, 2023

3d , 2023 WL 4191651 (C.D. PATDC82 II , 2023 WL 4191651, at *3. 2023 WL 4191651, at *8. Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.” PATDC82 II , 2023 WL 4191651, at *10. 2023 WL 4191651, at *17 (discussing “excerpts of two depositions” of “prescribing physician[s]”).

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C. 2023 WL 2386776, *3. In Beaver v.

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