04
Nov

Question: Which former acting deputy director of OGD just competed in Orange Book Jeopardy at AAMs Virtual GRx-Biosims Conference?

Answer: Who is Bob Pollock? Next week, November 9-11, the Association for Accessible Medicines (AAM) will be hosting a virtual version of the GRx+Biosims conference. As a part of it, an Orange Book Jeopardy was held between 3 Orange Book virtuosos: Kurt Karst of Hyman, Phelps & McNamara, David Rosen of Foley Lardner, and our […]

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18
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

ERRATA for JUNE 16, 2020 POST* – OGD Updates April 2020 Stats and Reports Official May 2020 Approvals, CRLs, and New ANDA Receipts

The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month).  OGD also acknowledged 65 new ANDAs in April. Of the […]

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13
Mar

Coronavirus Readiness

  As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]

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13
Feb
Fingerprint

What Is It? – Identity Testing Re-visited

In earlier blogs, we have written about specific technical items related to identity testing.  However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

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12
Feb
financial spreadsheet report

Promoting Confidence Through Product Quality – OPQ 2019 Annual Report

   The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products).  The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]

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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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04
Oct
OGD Updates August 2019 Metrics Image

OGD Updates August 2019 Metrics

August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications.  Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review […]

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