Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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. 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 4th 1263 (9th Cir.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.”

Testimonials 59

Testimonials Doctors Production Laboratories 59