FDA issues revised draft guidance for MDI and DPI quality considerations

The FDA has issued a revised draft guidance, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.”

The agency is requesting for written comments to be submitted within 90 days to the Division of Dockets Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The agency advises that all comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Electronic comments can be submitted to www.regulations.gov.

According to a draft of the Federal Register notice, “The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.”

View the revised draft guidance.

Proveris Scientific to present a poster on factors effecting multi-dose nasal spray characteristics at RDD 2018

Proveris’s Senior Applications Chemist, Heli Chauhan, will be presenting a poster (Poster #25) titled “Impact of Actuator Design on Multi Dose Nasal Spray Characteristics.” The Respiratory Drug Delivery Conference will be held from April 22nd through the 26th, 2018 at the JW Marriott Starr Pass Resort & Spa Tucson, Arizona. Please see our conference announcement to learn more about our involvement as a Silver Sponsor or contact us at sales@proveris.com to request a private meeting with us while attending RDD!

Proveris will also host an Exhibition Table (#74). We encourage attendees to stop by to learn about our lab services and high performance OINDP testing instruments, including our new Kinaero™ High-Throughput Fire Down System.