Looks like we all will be doing a lot of reading and assimilation of new information in 2021. The CDER Guidance Agenda – New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 contains 105 new and revised guidance documents that CDER plans to release this year. While there are a number […]
We are two-thirds through the reporting workdays for the month of January 2021 and OGD has reported 35 full approval actions and 4 tentative approval actions (total 39). If the pace of approvals does not pick up in the last 6 reporting days, we are set to have a total of full and tentative approval […]
Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry. COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry. High […]
On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”. This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency. As is no surprise, FDA clearly […]
While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed. The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]
In a continuing effort to deal with the number of ANDAs, supplements, and bioequivalence work and maintain a consistent and uniform quality of its reviews, the Office of Generic Drugs will be moving forward with a reorganization plan that will likely be effective sometime later in 2021. In the announcement received via email this morning, […]
As we hoped in our post here, the unofficial approval numbers for December were pretty good. As of postings on the FDA’s All Approvals list as of January 7, 2021 (here), OGD posted 63 full approval actions and 20 tentative approval actions for a total of 83, up from the November 76 total approval actions. […]
FDA’s ability to conduct on-site inspections has been significantly impacted by the COVID-19 pandemic. While the FDA is looking and utilizing alternate methods to conduct such inspections when needed, some of the alternate methods are, at least, as time-consuming as actual on-site inspections. Because of this issue and the Agency’s goal of being transparent, they […]
While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I. Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]
We got close when we reported the unofficial OGD approval actions (here) at seventy-seven and thirteen – well, the OGD’s official numbers were seventy-eight full-approval actions (the highest since May 2019) and fifteen tentative-approval actions for a total of ninety-three. The OGD reports that nine of the seventy-eight full-approval actions were for first-time approvals. Good way to […]
