Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

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. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation , 65 F.4th They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. ,

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Or does it suffice that a vaccine design has been approved in other countries? In Bruesewitz v. Wyeth LLC , 562 U.S.

FDA 59

FDA FDA Approval Testimonials Vaccine 59