Today, the FDA finalized an older draft guidance from August 2017 on repackaging of solid oral dosage form product from original containers into unit dose packaging that provides firms the ability to do so without (in most cases) performing additional stability studies. The Agency notes that it “received a few comments on the revised draft […]
In the Generic Drug User Fee Amendments Reauthorization Act (GDUFA II), OGD committed to provide a quarterly report with certain metrics regarding their workload and mean and median approval times for full approval actions and tentative approval actions. As you can see from the numbers below, the number of ANDAs awaiting action at OGD is […]
With five reporting days left in the month, the OGD reporting approval actions captured in the Daily Approvals list (here) and the All Approvals list (here) totaled fifty-eight full-approval actions and only four tentative-approval actions. This gives the OGD a chance to break the total approvals total for any month in FY 2020 if it […]
On Tuesday from 9:00-3:00 PM, the FDA held a virtual public meeting to obtain initial input from federal agencies, healthcare organizations, industry trade associations and other stakeholders in general on the reauthorization preparations for the third iteration of GDUFA. It is not known whether FDA will provide a link to the virtual program, as it […]
Proposed Law Would Provide Pathway for Generic Drugs Labeling Changes with a Reasoned Approach Proposed H.R. 5668 (here) titled, Making Objective Drug Evidence Revisions for New Labeling Act of 2020, outlines a path forward for making generic drug labeling changes when the reference listed drug is no longer marketed. We all understand the history of […]
Well, there were some hidden tentative approval actions that must have been posted fairly late after June was over as the OGD official numbers released for June show OGD had 14 Tentative Approval (TA) actions (we reported just 5 in our post on July 6 [here]). (However, when looking at the FDA all approvals list […]
FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020. The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]
Well, June was apparently another good month for the OGD FDA work-from-home teams as the unofficial counts of the numbers show they managed 74 full approval actions and 5 tentative approval actions. The 74 full approval actions represented the highest total in a single month thus far in FY 2020, beating the next highest of […]
This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted […]
The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2. Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]
