The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies …
The Food and Drug Administration (FDA) published the final guidance for industry entitled “Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.” This guidance finalizes the draft guidance for industry of the same title issued on October 21, 2022.
The U.S. Food and Drug Administration (FDA) recently published the guidance for industry, QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025). This guidance provides recommendations to help ensure clinically relevant information on heart rate-corrected QT (QTc) interval prolongation (certain changes in the electrical activity of the heart) is included in the U.S. Prescribing Information of non-antiarrhythmic prescription …
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
