Complete Response Letters Reach 3rd Highest Monthly Total Under GDUFA

February saw the 3rd largest number of Complete Response Letters (CRLS) issued (129) in a single month since the implementation of GDUFA. Previous highs were 134 in July FY 2015 and 130 reached in November FY 2013. With the review machine gearing up, wouldn’t one expect the number of CRLs to be steadily increasing each month? Maybe not! If the information requests (IRs) keep flying out the door along with easily correctable deficiencies (ECDs), then maybe the number of CRLs will remain lower. Or is that wishful thinking? That logic would seem to mean that the number of approvals should be soaring. Well, if you look at the total number of approval actions plus the number of CRLs, the total has actually been going up, and why? Because the number of monthly approvals has increased in FY 2016!

Another GDUFA Goals Letter Surprise – Have you Gotten One of These Missives Yet?

The generic drug industry complained about the GDUFA Goals Letter in the past, when it thought it had negotiated more than goals for Complete Response Letters (CRLs) rather than clear movement towards application approval. Well, some three years into GDUFA I, there now seems to be a better understanding of what industry thought they got and FDA has adopted, albeit outside of the direct language in the Goals Letter, policies that are driving application towards approval.

MaPP 5240.3 on Prioritization of Original ANDAs, Amendments, and Supplements Gets a Facelift

Life is always a picnic and deciding what to bring is sometimes a chore. The key is to assure there are no ants! Well, the generic industry has waited to hear what would be brought to the prioritization picnic and now the third revision of the MaPP 5240.3 lays out the meal. The entire MaPP should be reviewed and studied carefully so you best understand the FDA position on priority and expedited review.

Another Sterile Compounder Under Fire from FDA

FDA issued an alert today telling healthcare professionals and patients not to use human and animal sterile drug product produced by a firm in Austin, Texas. After FDA inspection of the facility which found many objectionable conditions, the Agency recommended that the firm recall its products and cease production until the problems identified were corrected. 

Pediatric Study Plan Guidance Updated by FDA

Today, FDA issued a revised draft Guidance document entitled, Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.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,

TADs – Can OGD Meet the Aspirations of Industry?

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.

OGD February Original ANDA Receipts Are 2nd Highest in FY 2016

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.

Cook Says FDA is Delivering at OGD Update During GPhA meeting

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.

Gottlieb Panel Feels the Tension with OGD

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).

FDA Finalizes Guidance on Low Molecular Weight Heparin Characterization and Immunogenicity Considerations

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. 

More on the New Guidance Documents FDA Plans to Issue in 2016

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,