FDA Law Blog: Biosimilars

OCTOBER 24, 2024

In a landmark 2013 decision , a unanimous Supreme Court held that a naturally occurring DNA segment, even when isolated, is a product of nature and therefore does not meet the subject matter eligibility requirement for patentability.

Laboratories 64

Laboratories DNA Testimonials Biosimilars 64

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Biosimilars Regulations 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. They excluded bogus expert testimony under Fed. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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