GSK moves its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data.
CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and regulatory review.
FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.
Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-labeled carbon), indicate...
Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated for treating seizures ...
CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer advertisement for m...
FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.
FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.
