30
Jan

December OGD Metrics Updated

The Office of Generic Drugs (OGD) updated its December 2019 (first quarter FY 2020) statistics with metrics, in addition to the approvals, receipts of original ANDAs, and complete response letters that were published a few weeks ago. The OGD reported refusing-to-receive (RTR) four ANDAs, three standard review and one priority review application.  While four is […]

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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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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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30
Oct
Drug Shortages Report Provides Look Forward Image

Drug Shortages Report Provides Look Forward

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem.  Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy.  There has even been one firm created […]

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