November 2019

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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21
Nov
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New and Revised Product-Specific Bioequivalence Guidances Announced

In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations.  While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active […]

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19
Nov
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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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19
Nov
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CVM Issues Guidance on Enforcement Policy Regarding the Compounding of Vet Drugs Using Bulk Drug Substances

In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals. Unlike the statute and regulations for human drugs, there are no provisions for compounding animal […]

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15
Nov
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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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11
Nov

Lachman Consultants’ Team Teaches Young Professionals How Properly Preparing For and Addressing FDA Form 483 Ultimately Helps Save Patient’s Lives

(Westbury, NY – November 2019) Spanning approximately 120 minutes, part of the executive team from Lachman Consultant Services, Inc. (“Lachman Consultants”) guided 45 young professional engineers and chemists through an introduction to current Good Manufacturing Practices (“cGMP”) during ISPE’s 2019 Annual Meeting. As a leading provider of expert compliance, regulatory affairs and technical services to […]

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11
Nov
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The Complexity of Complex – Explained at Least in Part

On Wednesday afternoon at AAM’s GRx+Biosimilars Conference in Bethesda, MD, the FDA held a valuable workshop on Complex Generic Drug Products.  The workshop opened with a general session explaining the opportunities for interacting with the FDA to get guidance and input while developing your complex generic and preparing your ANDA and how to get the […]

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