New Paragraph IV Listings – Some Interesting Observations

The FDA’s paragraph IV (PIV) database is designed to give applicants and potential applicants information relative to first-to-file opportunities. FDA does this for two reasons: 1) it gives applicants assurance that their product is a first-to-file if the acknowledgement date (date acceptable for filing) on their letter from FDA officially receiving their application matches the date of submission in the PIV database. This has eliminated the many calls to the Office of Generic Drugs (OGD) to find out if their submitted application holds a potential first-to-file seat; 2) the listing also informs potential applicants that at least one ANDA has been submitted with a PIV certification and allows others to decide if they wish to enter the fray and expose themselves to litigation.

Despite FDA and Industry’s Efforts, Drug Shortages Continue

Over the last few days, FDA has posted information on new and updated drug shortages with 6 new shortages listed over the last week. We have noted the problems that drug shortages create in previous posts and we have all followed the media accounts of the problem; however, it still seems that, while many of the causes of drug shortages have been identified, stopping them from happening in the first place appears to be more elusive than any regulation, required notification or interaction with regulatory bodies can resolve.

Particulate Matter in Parenteral Products – Why So Much?

Last week while waiting for my flight home at an airport on the east coast, I decided to look at the recalls listed on the CDER web page. I realize that I have read about a number of recalls of parenteral products recently and those recalls were for a number of different firms, but what caught my attention was that 12 of 25 recalls listed were for visible particulate matter (including glass particles).
While I am not a manufacturing expert by any stretch of the imagination, I started to wonder why this might be.

Two Long Time OGDers to Oversee the Quality and Consistency of Regulatory Actions, and New Acting Appointees Announced!

Having heard about an important announcement made by OGD last week, I was fortunate enough to receive a copy of an internal email issued by Cook from the CDER trade press office. I read it once, and then reread it about 5 more times. “More changes at OGD” was the bottom line message, and then a question popped into my head. Is this message good news? If it results in more consistent actions coming out of OGD quicker, the answer is yes!

2 New MaPPs (to Somewhere) that Provide Direction on ANDA Supplements and Amendments

The 2 new MaPPs: 5200.4 Criteria and Procedures for Managing the Review of Original ANDAs, Amendments and Supplements and 5240.3 (a revision of the old 2006 MaPP entitled Review Order of Original ANDAs, Amendments and Supplements) Prioritization of the Review of Original ANDAs, Amendments and Supplements were released today by FDA. These two MaPPs describe how the Office of Generic Drugs (OGD) will prioritize review of ANDAs.