The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.
On Monday we posted about an issue that was brought to our attention relative to OGD’s position on goal date assignment, or lack thereof, to an ANDA with unresolved eCTD problems. We provided examples of some of the issues that firms were finding and we found that while there is merit to asking firms to […]
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.
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.
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. […]
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 […]
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).
