On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”. The original guidance was published November 13, 1998. The revision spans some 50 pages of discussion about critical quality attributes, quality target product profiles, development of controls, stability, container closure systems, product and process development, labeling and information to be submitted in an application (whether it be for an NDA or ANDA). There are also a couple of appendices to help applicants better understand MDI and DPI product characterization studies and approached to evaluating delivered dose uniformity.
While we did not have time to do a side-by-side of the 1998 guidance, it Is clear that this guidance document provides industry with FDA’s current thinking and expectations on quality aspects and labeling topics of today germane to these products. The one thing that is not covered is how much different an ANDA can be from its referenced listed drug (RLD) product and still qualify for submission and approval as an ANDA. Based on the difficulty that OGD has in finding a drug/device combination for some popular inhaled products the “same as” the RLD (e.g., Advair Diskus), we know that this decision will be handled on a case-by-case basis; thus, it is difficult (if not impossible) for FDA to provide substantive and meaningful advice. They will know it when they see it!
If you need some good bedtime reading, the new guidance can be found here. You are guaranteed to doze off quickly, but you may have bad dreams about huffing and puffing!
