Top Excipient DMF Problem Areas for FDA Include Authorization Letters, Paper Filings, and Annual Reports

FDA wants the excipient industry to better understand the challenges that the agency faces in reviewing drug master files (DMFs) and to improve their filings so that they do not impede the drug application process.

At a DMF workshop held in conjunction with the IPEC/ExcipientFest conference in Raleigh, NC in late April, FDA DMF expert Art Shaw gave the participants an insider’s view of what the excipient DMF process looks like from the reviewer perspective and where and how shortcomings in the filings are making the process more difficult.

Key current DMF problem areas, he noted, include: ● the Letter of Authorization (LOA) ● paper rather than electronic filings, and ● annual reports.

In his presentation, Shaw offered valuable advice on how to avoid pitfalls and expedite reviews.

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