ThromboGenics’ Jetrea Clears Advisory Committee On Strength Of Unmet Need
FDA urged consideration of additional pre-market safety studies for the vitreomacular adhesion product, but desire for an additional treatment option for a condition that at present is treated only with surgery overrode potential concerns about visual acuity side effects.
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Center for Drug Evaluation and Research tells FDA Commissioner Margaret Hamburg that resource and regulatory policy considerations warrant postponing action on ISTA’s request for a formal evidentiary hearing on its rejected application for a larger fill size.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.