Drug Target Review

JULY 4, 2023

The global ADC market is expected to continue this steep upward trajectory and is anticipated to exceed $16 Billion by 2026. 1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Translational and Clinical Pharmacology [Internet].

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2026 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Patient-Focused Drug Development FDA must issue or update guidance regarding the Agency’s collection of information from medical device facilities prior to inspection.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations 40

Regulations FDA Science Production 40