Language in FDA Decisions Could Signal Increased Scrutiny in Approval Decision-making

The wording in the US Food and Drug Administration’s (FDA) recent decision not to approve Pfizer and Myovant’s endometriosis application may signal a tightening of the agency’s standards for regulatory approval. The key phrase drawing attention is, “deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.” So far, 14 companies have received a similar comment from the agency recently.

According to Kevin Dunleavy of Fierce Pharma, “Of the 14 such notifications, 11 eventually resulted in complete response letters, the analyst pointed out. The other three—including Myovant and Pfizer’s bid for Myfembree in endometriosis—have yet to be resolved. But receiving a “deficiencies” notice is hardly a death sentence for a drug. Of the 14 companies notified, Antares and TherapeuticsMD worked to gain approvals, while several others have new target dates set for this year.“

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(Source: Fierce Healthcare, April 13^th, 2022)