Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. .” ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .” to include devices.

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Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th Monsanto Co. ,

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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). 2016), and In re Zantac (Ranitidine) Prods. Wyeth , 85 A.3d 3d 434 (Pa. 3d 1034 (S.D.

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Drug & Device Law

APRIL 18, 2022

2016), “ Probably the Best Wisconsin Law Decision We’ve Ever Seen.” make clear that Wisconsin adopts the doctrine, as consistently predicted by Wisconsin federal courts since 2016. Wyeth Pharmaceuticals , 471 F. We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation , 218 F. 3d 700 (N.D.

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Drug & Device Law

MARCH 4, 2024

2016) (citation omitted). Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” 2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been found inadmissible. . .,

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