Today, FDA issued a revised draft Guidance document entitled, Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. Quite a mouthful, but exceedingly important if you plan on submitting an NDA that is subject to PREA (Pediatric Research Equity Act). Firms (of course) want to gain an additional 6-month extension on any existing exclusivity and have another 6-month period of protection,
The TADs, as described by Dr. “Cook” Uhl, OGD’s Director, are only aspirational in nature. This fact has been clear to the industry since the inception of the TAD program and their assignments. To be clear, industry is thankful for the TAD program and does understand the difference between GDUFA fixed goal dates and the aspirational TAD. But, in most instances, human nature has a way of looking for the positive in any situation and, in the case of TADs, industry must accept that their aspirations and the ability of OGD to meet these aspirational dates may not always intersect.
The yin and yang between approvals and receipts of original ANDAs is always a balance that the Office of Generic Drugs (OGD) must deal with, and OGD only has control of one of these metrics. The number of original ANDAs submitted in February was the second highest for FY 2016 with a total of 62 received. This pales in comparison with the December figure of 180, but is still indicative of the fact that OGD can expect more applications this year than last.
The Office of Generic Drugs (OGD) fully approved 51 ANDAs and tentatively approved 12 ANDAs this past month. Given that February is a short month (albeit this is a leap year), OGD approval numbers are consistent with past performance so far this fiscal year.
Dr. Kathleen “Cook” Uhl, Director of the Office of Generic Drugs provided an update on the progress of OGD in the implementation of GDUFA I. Despite the “tension” and uncertainty noted by the panel that preceded her (see yesterday’s post), Cook delivered a strong message that OGD has meet all of its GDUFA goals to date and has gone above and beyond the goals outlined in the GDUFA goals letter.
Scott Gottlieb, MD hosted a three-person panel on the closing day of the GPhA Annual Meeting just before Dr. “Cook” Uhl presented the Office of Generic Drug (OGD) update. Scott fired questions at Kate Beardsley (Beardsley Law PLLC), Sheldon Bradshaw (former Chief Counsel FDA and now a partner with Hunton and Williams LLP), and Frances Zipp, (President and CEO, Lachman Consultants).
Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here). The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products. The document provides guidance for NDA holders (for new products or changes to existing products) and for ANDA applicants.
Well, we did not have to wait long after the blog post on upcoming Guidance documents for the DMF Completeness Assessment (CA) Guidance to issue (here). The document begins with a concise discussion of the GDUFA requirements for DMFs submitted to support approval of generic applications, including the requirements for fees,
On January 25, 2016, this blog posted an article about some of the Guidance documents that FDA was planning to issue as new and or revised this coming year (here). In that blog post, it was noted that an update to that post would be coming-well here it is!
Some of the other notable documents we can all be looking for this year (with a little bit of editorializing) include,
Most know that when a 505(b)(2) contains the results of a clinical study other than a bioequivalence study, the application will be assessed a full PDUFA user fee. However, did you know that if you file a 505(b)(2) application that relies on published clinical studies, your application may also be subject to the full fee?
The number of approvals reported yesterday was revised upwards by 1 to 43, according to the Office of Generic Drugs (OGD).
The Washington DC. / Maryland “snowmageddon” event causing the closure of the Federal Government for a few days may have resulted in a dip in ANDA approvals in the first month of calendar year 2016. The Office of Generic Drugs (OGD) fully approved 42 ANDAs and tentatively approved 17 ANDAs in January.
According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income. The article provides an estimate of $1.3 -1.6 billion annually.
With the flurry of FDA enforcement actions on pharmacy compounders,
I recently read a very interesting article about some big vitamin companies and their stock performance. I think that it deserves some attention because, when people outside of the Food and Drug Community start writing about potential problems, and when those problems translate into increased FDA enforcement actions, then Congress takes note and then (all of a sudden) laws get rewritten and regulations get passed and, the next thing you know, a segment of the industry is changed forever – or at least until the next time the government changes its mind.
As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.