Approvals

06
Feb
Abstract Molecular Structure

Revisiting the “Novelty” of Novel Excipients

February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here).  In this notice, the FDA had proposed a pilot program related […]

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22
Jan
Terrified businessman with crystal ball

Two-Thirds of the Way through January, Approval Action Totals Signal A Below-Average Month

With seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions.  The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions.  Unless the end of the month picks up, we could see the slowest month for […]

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12
Dec
2019 Approvals

November 2019 Approvals and Receipts Official Numbers

Based on our post previewing the November totals, there were some late added approvals that did not initially show up on the Agency approval databases.  We reported 49 full approval actions and 8 tentative approval actions on December 3rd.  With the release of the official November numbers (here), OGD issued 59 full approval actions and […]

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05
Dec
Backlog Photo

How Much Does the Clear Out of the Backlog Really Impact Approvals?

Reading Derrick Gingery’s article “ANDA Approval Records Will End As U.S. FDA Mops Up Backlog” (here) in today’s Pink Sheet about Dr. Woodcock’s contention that the clearance or “mop up” of the backlog will impact the number of generic drug approvals, I was somewhat stopped in my tracks.  Granted, the backlog of old applications did […]

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