Three Major FDA Adcomms on the Horizon

As May approaches, the US Food and Drug Administration (FDA) is planning for three advisory committees that have major implications for healthcare in the US. The first will review Perrigo’s over-the-counter contraceptive. Next, a committee will examine an intranasal epinephrine spray for severe asthma. The final will focus on a yet unnamed product from Intarcia Therapeutics.

According to Katherine Lewin, “The letter does not specify what the adcomm for Intarcia will be about, but by August of last year the company’s leaders had left and the FDA had denied Intarcia’s request for a hearing to review the company’s twice-rejected type 2 diabetes drug candidate and proprietary delivery system. At the time of the FDA’s denial, the agency cited device and product quality issues and clinical deficiencies.”

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(Source: Endpoints News, March 28^th, 2023)