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Expand labeling for testosterone replacement therapy, FDA panel says

Members of an FDA expert panel urged the agency to expand labeling for testosterone replacement therapy and remove its classification as a controlled substance. Like previous FDA expert panels, the ...
TCTMD

FDA Panel Talks Labeling, Urges Cooperation for Paclitaxel Mortality Signal in PAD

(UPDATED) In an underwhelming finale to 2 days of debate and discussion over a long-term mortality signal associated with paclitaxel-based devices for PAD, the Circulatory System Devices panel of the ...
Healio

FDA panel votes against labeling endorsing single bottle drops for both eyes following cataract surgery

SILVER SPRING, Md. — A U.S. Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee voted down a proposal to open labeling for anti-inflammatory postoperative eye drops to ...
STAT

In expert panel, FDA says ‘door is open’ for testosterone labeling revisions

Annalisa (Nalis) Merelli is a contributing writer at STAT focused on boys’ and men’s health. Exactly a month after it announced the removal of black box warning labels on estrogen therapy products ...