20
Dec

December May Not Be a Month to Remember for OGD Approvals

Taking a look at the unofficial approval information on the FDA website through December 16th, we found only twenty‑five ANDAs receiving full‑approval actions and six receiving tentative‑approval actions.  That is a total of (obviously) thirty‑one approval actions.  Given that number, if the OGD could double its approval output by the end of the month, that would […]

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16
Dec

New Reporting Structure and Metrics for OGD Statistical Reports

Well, the new statistics started rolling off the assembly line last night and appear in a new report that combines the generics monthly statistical report and the Quarterly Report.  The new name of the report, which we discussed in a blog post (here), is the Generic Drugs Program Monthly and Quarterly Activities Report.  We will […]

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15
Dec

Newly Revised Guidance on Failure to Respond to a CRL

The FDA has revised the guidance, originally issued in July 2022, titled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (here) to include additional information as required relative to the performance goals outlined in the commitment letter for GDUFA III.  While there aren’t many changes in the revision, it is certainly […]

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14
Dec

Bi‑Yearly Update of Off‑Patent Off‑Exclusivity Drugs with No Generic Approvals

Twice a year, the FDA publishes an update of the List of Off‑Patent, Off‑Exclusivity Drugs without an Approved Generic (see here).  This list is designed to generate interest from the industry in increasing competition among such products.  It is made up of two parts.  Part I is for drugs for which the path to approval is […]

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12
Dec

Are your Analytical Methods Processing Settings Part of Your Analytical Lifecycle Management Program?

Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global  health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]

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06
Dec

November Is “Unofficially” in the Books – OGD Approval Numbers Await Official Publication

Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers.  At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry. We […]

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29
Nov

Where Have All the Official Stats Gone, Long Time Passing!

The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance.  The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]

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29
Nov

Accelerated Approvals – Here Is One to Watch

It is always interesting to see how the Agency works when one action could trigger another action.  In the Federal Register pre-publication page (here) this morning, the “Food and Drug Administration (FDA) [announced that it] is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON® (Mafenide Acetate, USP) Powder for 5% Topical Solution, held […]

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