Petitions

31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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03
May

Is the New Proposed Legislation (S-1462) Regarding ANDA Suitability Petitions as Good as it Sounds?

The ANDA suitability petition process has been languishing for years.  Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition.  Today, I read […]

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23
Jul

Potential Label Carve Out to Antidepressant Appears OK to FDA

In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here  ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]

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