FDA reopens comment period for draft guidance on MDI and DPI quality considerations

The FDA has issued a notice that it has reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018. The FDA originally gave interested parties until June 18, 2018 to submit input; the comment period has now been extended until September 18, 2018.

At RDD 2018, the FDA’s Rik Lostritto presented a talk on the then newly released guidance that was met with numerous questions about procedures and about the scope of the guidance. At the time, Lostritto said that he would be open to extending the comment period but warned that major changes to the scope of the document could delay the issuance of a final guidance.

According to the July 20, 2018 notice, “The Agency believes that reopening the comment period for an additional 60 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying Agency decision making on these important issues.”

Read the FDA notice.

Read the draft guidance.