15
Jun

A New MaPP and a Lot of Red Tape?

A day or so ago, the FDA released Manual of Policy and Procedure (MaPP) 5021.5 titled Assessment of Facility‑Based Deficiency Major‑to‑Minor Reclassification Requests.  A MaPP is a document that informs how the FDA will handle, manage, and prosecute a particular issue internally.  In this case, it describes how the FDA will adjudicate a request to […]

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14
Jun

Where Have All the RLDs Gone? Long Time Passing! PANDAs Still Appear to Fill Some of the Bill!

Innovators often discontinue products when they are no longer profitable.  And, as we all know, to file an ANDA as a duplicate of an approved NDA product, the ANDA applicant must refer to a Reference Listed Drug (RLD) approved for safety and efficacy under section 505(c) of the Act.  There are times when an ANDA […]

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