06
Dec
Training Fundimentals

Training Fundamentals: Important to Baseball and the Analytical Laboratory

Training Fundamentals: Important to Baseball and the Analytical Laboratory By Tim Rhines, Ph.D | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology |  3 | Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training.  At this time, team management is evaluating where the team succeeded and where improvement is needed.  It […]

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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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04
Dec
Novel Photo

Novel Excipients – FDA Evaluates a Novel Program

Excipients are components used and intentionally added to a drug product with no expectation that they will have a therapeutic effect.  A novel excipient is one that has never been used and “reviewed in an FDA approved drug product or does not have an established use in foods”.  Since the beginning of time, the Agency […]

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25
Nov
Stupid Is Image

Stupid Is as Stupid Does – Why Aren’t Generic First Approvals Automatically on Medicare Part D?

I read four articles this morning (here, here, here, and here) about Medicare and how it can take years to get a generic drug placed on the appropriate tier for coverage after a first generic is approved, and it just makes my blood boil.  With all the press about lowering drug prices and knowing that […]

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19
Nov
Thanksgiving Horizon Image

With Thanksgiving on the Horizon, November ANDA Approvals Status

With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs.  Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month […]

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15
Nov
Withdraw Applications Image

FDA Proposes to Withdraw Applications – Failure to Submit Annual Reports

In a prepublication of the Federal Register today, the FDA announced its intentions to withdraw four NDAs (see chart below) for failure to submit required annual reports.  In the notice, the Agency noted the firms have been contacted by the Agency but have repeatedly failed to submit the required reports.  The Notice provides the firms […]

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