FDA Says DMF Filings Held Up by Inadequate Information on Starting Materials
This article was originally published in The Gold Sheet
FDA officials say that only 14 percent of Type II drug master file completeness assessments are being approved in the first review cycle and urged industry to meet with them via the 10-day teleconference to resolve issues early on. Inadequate information on starting materials is a major deficiency and one of the most intractable problems found in API DMF filings, they say.
You may also be interested in...
The quality of DMFs is expected to improve thanks to a soon to be released question- based review system for DMF holders as well a recently issued draft guidance calling for new procedures for reviewing master files called “completeness assessments,” said a pharmaceutical industry official who was a former team leader in FDA’s Office of Generic Drugs.
After five years, working group members of the International Conference on Harmonization have adopted its Q11 guideline on drug substance development and manufacture, which advances QbD principles for drug substance development, especially for biotechnology products, endorses the use of prior knowledge, and establishes a harmonized definition for starting materials. Even though not everyone is happy with this definition, ICH members say that a harmonized definition is better than a non-harmonized one.
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.