Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Drug Target Review

OCTOBER 3, 2024

Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. There are several high-level takeaways from these updates for drug developers.

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,

FDA 40

FDA Laboratories Regulations Production 40

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52