A review of FDA approval times for OINDPs presented at the recent IPAC-RS conference verifies that the process has sped up considerably over the last decade. According to the poster authored by Ray Ormiston of IPAC-RS’s Global Regulatory Affairs and Outreach Committee, whereas most of the 20 OINDP submissions from 1992-2003 took 2-3 years for approval, and several … [Read more...] about FDA approval times for OINDPs have decreased
Features
RDD Europe organizers expect largest meeting to date
RDD Europe 2011 will be the largest iteration so far of the European version of the Respiratory Drug Delivery meetings, says Richard Dalby of co-organizer RDD. Already, more than 400 people have registered for the May 3-6 meeting to be held at the Dorint Hotel Convention Center Berlin (formerly the Intercontinental). Anyone planning to register on site should know … [Read more...] about RDD Europe organizers expect largest meeting to date
Another FDA group seeks to review OINDPs
The 2011 IPAC-RS conference, held in Rockville, MD March 29-31, featured speakers from a number of FDA offices discussing the agency’s efforts relevant to orally inhaled and nasal drug products (OINDPs). Among those speakers was Ronald Kaye, Human Factors Pre-Market Evaluation Team Leader from the Office of Device Evaluation in the Center for Devices and Radiological … [Read more...] about Another FDA group seeks to review OINDPs
IPAC-RS conference — Day 2
Speakers representing the FDA and several IPAC-RS working groups dominated day 2 of the 2011 IPAC-RS conference, with presentations and panel discussions on the day's main topic, "Product Quality." The day began with the keynote address delivered by Prasad Peri of the FDA's Office of New Drug Quality Assessment and concluded with the announcement of the poster … [Read more...] about IPAC-RS conference — Day 2
IPAC-RS conference — Day 1
Day 1 of the 2011 IPAC-RS conference featured 13 talks and a panel discussion, covering two topics aligned with the conference theme of "Bring Value to the Patient in a Changing World." The morning focus, "Voice of the Customers," included presentations by clinicians, a patient education specialist, and the FDA Office of Special Health Issues, in addition to a report … [Read more...] about IPAC-RS conference — Day 1
Inhalation IP up for sale at live auction
On March 31, 2011, 150-200 prospective buyers will gather in a Beaux Arts ballroom in New York City for ICAP Ocean Tomo's Spring 2011 Live Auction. After having attended a welcome dinner the previous night featuring keynote speaker Malcolm Gladwell, the attendees will get down to the business of buying intellectual property amid the Corinthian columns and marble … [Read more...] about Inhalation IP up for sale at live auction
Can patients learn to use MDIs?
Numerous studies have described the difficulties patients experience in using metered dose inhalers (MDIs), including a recent article in the Journal of General Internal Medicine (JGIM) that found 86% of hospitalized patients enrolled in a study unable to properly complete at least 75% of the steps necessary for effective use of an MDI. As with many such … [Read more...] about Can patients learn to use MDIs?
Young OINDP researchers on the job hunt
On the second day of the Drug Delivery to the Lungs meeting in December 2010 (DDL 21), Xiang Kou, a grad student from the National University of Singapore who had been spending time as a visiting scholar at Purdue University, was approaching the end of his presentation on “Direct observation of particle dispersion mechanisms in DPI using particle image … [Read more...] about Young OINDP researchers on the job hunt
An update on EPAG activities related to the Abbreviated Impactor Method (AIM)
The Impactor Sub-Team of the European Pharmaceutical Aerosol Group (EPAG), a consortium of pharmaceutical companies that develop pulmonary and intranasal drugs, has focused its attention on the potential benefits of the abbreviated impactor method (AIM), a fast screening technique to provide a good estimate of the potentially respirable and non-respirable … [Read more...] about An update on EPAG activities related to the Abbreviated Impactor Method (AIM)
The upcoming IPAC-RS conference features updates from FDA representatives
At the next IPAC-RS conference, March 29-31 in Rockville, MD, sponsored by the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS), OINDP specialists will have uncommon opportunities to interact with regulators, representatives of patient organizations, and clinicians. The meeting, titled “Bringing Value to the Patient in a … [Read more...] about The upcoming IPAC-RS conference features updates from FDA representatives