19
Nov

OGD Reports Approvals Receipts and CRLs for October 2020 – with a Couple of Surprises!

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 […]

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10
Nov

Tidbits from the Monday AAM Afternoon Sessions – and Pay Close Attention to Little viii Carve Out Issue

We all know you can’t be in two places at once (although it would certainly be handy at times).  That applies to the Association for Accessible Medicines (AAM) meeting as well.  While there are lots of good sessions, as a one-man band, some tough choices had to be made. Let’s tackle one of the most […]

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05
Nov
Drawing of a happy smiling emoticon on a yellow paper and white background.

October 2020 Best Month in Last Eighteen for Generic Approvals

Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months.  That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions.  Why do […]

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03
Nov

FY 2020 Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance

The FDA released its FY 2020 quarterly report of the Generics Drug Program late yesterday.  By the numbers, mean approval times reported by quarterly cohort have not changed significantly from quarter to quarter, and are driven by the age of the applications ready for and approved in that quarter. The Generics program has approved more […]

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27
Oct

FDA Finalizes Guidance on Referencing Approved Drug Products in ANDA Submissions

Initially issued in draft in 2017, the document “Referencing Approved Drug Products in ANDA Submissions – Guidance for Industry” was issued in final today.  It addresses the difference between the reference listed drug (RLD) (that must be cited as the basis of the ANDA submission) and the reference standard (RS), and provides details of how the […]

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16
Oct

End of FY 2020 Approvals, Receipts, CRLs, and Updates to August Metrics

FDA reported 70 full approval actions and 15 tentative approval actions in September for a total of 85 approval actions for the month.  The 85 approval actions fell into the second most approval actions in FY 2020 behind only April’s total of 87.  The full approval action in September was also the second highest this […]

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07
Oct

Are ADHD/Stimulant Drugs Dropping Off the FDA’s ADF Radar?

This morning, in reading an article from the Pink Sheet written by Sarah Karlin-Smith, I flashed on my blog post from September 24, 2020 (here) discussing the new warning on benzodiazepine products.  In this post, I had expressed concern that the abuse-deterrent formulation (ADF) craze of opioid formulations might be creeping in on other products […]

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