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Latest Blogs

Two-Thirds of the Way through January, Approval Action Totals Signal A Below-Average Month

With seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions.  The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions.  Unless the end of the month picks up, we could see the slowest month for approval actions this FY.

“Complete” Means “Complete”

“Complete” seems like a simple unambiguous word.  So why do so many firms struggle with complying with the following two predicate rules of cGMP compliance?

  • 21 CFR 211.188 Batch production and control records (here)

“Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch.”

  • 21 CFR 211.194(a) Laboratory records (here)

“Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards,

December 2019 Approvals and Receipts – Big Month for New ANDAs

With the end of the first quarter of FY 2020 approaching, the official numbers from FDA show a big jump from the meager number of new ANDA submissions the first two months of this FY with the December receipts hitting a 2 year high at 149.  Of course, this is likely due to getting the submission in to meet end of the year goals for industry,

FDA Evaluating Diet Drug Risks for Increase in Cancer Rates

In a January 14, 2020 Drug Safety Communication (here), FDA discusses an alert to patients taking the weight loss drugs Belviq or Belviq XR (lorcaserin) of a potential increase in the risk of cancer.  The NDA drug products were approved on July 27, 2012 (immediate-release) and July 15, 2016 (extended-release version),

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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.

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 life sciences clients worldwide,