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January 2020 Approvals Well Below Average

The official OGD stats are out for approval and tentative approval actions, as well as complete response letters issued and receipts of original ANDAs.

In January 2020, OGD issued 49 full approval actions, the lowest by far for FY 2020. Of those 49, only one was cited as a first-time approval (I think this might be an error in reporting,

CBER Publishes a Boatload of New Gene Therapy Guidances


January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents!  A total of six final guidelines and one draft guideline on GT products were issued.  These included:

  • Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications (here)
  • Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up (here)
  • Long Term Follow-Up After Administration of Human Gene Therapy Products (here)
  • Human Gene Therapy for Rare Diseases (here)
  • Human Gene Therapy for Retinal Disorders (here)
  • Human Gene Therapy for Hemophilia (here)
  • Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations (here)

These guidances will be extremely valuable to the exploding field of gene therapeutics,

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 of pharmaceutical drug products.

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 on what OPQ has accomplished since its inception in 2015,

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Scott Deckebach, M.B.A., new Director in the Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Scott Deckebach has accepted the position of Director in the Compliance Practice at Lachman Consultants, effective January 27, 2020.

Mr. Deckebach is a life sciences and medical device regulatory compliance, manufacturing, and technology expert with more than 25 years of experience in the industry. Mr. Deckebach has been affiliated with Lachman since 2015 when he joined the Compliance team as a Senior Associate.

John Darby, new Senior Director in the Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that John Darby has accepted the position of Senior Director at Lachman Consultants, effective December 2, 2019.

Mr. Darby is a goal directed, results-focused executive professional with a strong, global background in quality assurance, compliance, audits, training, and remediation. His 18 years of experience and keen insight contribute to his ability to identify issues and form innovative solutions and strategies for continued success.