FDA new draft guidance: Metered dose and Dry powder inhalers – Quality Considerations

PUBLISHED 9th May 2018

The FDA have produced a new draft guidance on Metered Dose Inhalers (MDI) and Dry Powder Inhaler (DPI) products, published on the 18th April. See https://bit.ly/2IrNNCl for a copy.

Comments and suggestions regarding the draft guidance should be submitted to the FDA by 18th June 2018. If desired electronic comments can be made to https://bit.ly/2KMczvi.

It is a revision to the original document published in 1998, updated to reflect current standards and requirements to enhance understanding of appropriate development approaches for these products. The document contains a lot of information with sections discussing critical quality attributes (CQAs), product development steps as well as describing specific information that must be submitted in an application for the inhalers.

However, the most relevant section for device usability and human factors can be found at the end of the document in Section J specifically looking at the labelling requirements for an MDI and DPI. The section is a set of recommendations for the labelling to help achieve consistency and uniformity in the content, product title and format.  Within the guidance the MDI and DPI labelling’s are separated into 4 main areas with points as to what should be included under each section:

  • Description section of the prescribing information
  • How supplied/storage and handling
  • Instructions for use
  • Container labels and carton labelling

The guidance does note that in the particular case of ANDAs (Abbreviated New Drug Applications) the application is required to include information to show that the labelling proposed for the generic drug is the “same” as the RLD, with certain limited exception. Drug delivery dosage is of particular importance for MDI and DPI and so it is also worth noting that the guidance gives an example of specific statements to describe the target delivery dose (TDD). Section B has a good description of the dosages and compositions clarifying the differences between the strength, the metered amount, and the TDD.

Medical Device Usability is encouraged to find that in recent years the FDA have drafted many documents, in particular related to combination products, to clearly define what the labelling requirements are. It is clear that labelling is of great importance to safe and effective use!