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Latest Blogs

Long Time Government/FDA Icon Bob West Passes Away

I woke up this morning to some sad news.  Bob West, former Public Health Service officer who spent some 40+ years in government service, passed away yesterday.  For those of you in the drug industry, the name Bob West meant a caring, rational, helpful individual.

Bob came to OGD after a stint with the Public Health Service’s hospitals and clinics and then after a number of years in New Drugs. 

Guidance on TA’ed Applications Deserves TA – Total Attention!

In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note:

“We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document.  

Shutdown Woes May Also Hit Ten Months After FDA Receives Funding

The Office of Generic Drugs (OGD) has taken great pride in meeting all of its GDUFA goals (including most, if not all, ANDA review goal dates).  But, Houston, we may have a problem!

Here are some facts that may have the OGD worrying into the future:

  1. December is typically one of the largest months for submissions.

Official December 2018 Approval Numbers In – But What’s Missing?

OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100.  This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here).  Not bad, considering the short month with vacations and the Federal government shutdown that started December 22 so actually represents a better result than what we anticipated.

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Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

Compliance 360 – A podcast survival guide to US FDA enforcement and compliance

Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.

Compliance 360° is hosted by Medtech Insight

PODCAST LINEUP

November 28,