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reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018.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.
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Read the draft guidance.
