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Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA and industry experts has offered compliance, regulatory affairs, and technical services to clients around the world.
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Complex Generics Get a Shot in the Arm (Leg Actually!) with First Generic Epinephrine Auto-injector Approval

The FDA announced today (here) the first approval of a generic equivalent to Epi-Pen, the combination product used to treat severe allergic reactions.  The FDA’s announcement acknowledges that approval of “complex” generics, like some combination (drug/device) products, can be very challenging.

The FDA has always said that for most complex drug device products,

Scammed Into a Blog Post as MaPP 6020.4 Pops up on News Feed

Well, after a couple of comments on my post (here) regarding timelines for resubmissions of MDAs, BLAs, and efficacy supplements, it came to my attention that this was an older MaPP.

Sorry for the confusion but it came up as new on a daily feed I routinely review for blog material. 

NDA and BLA Resubmission Review Timelines Outlined in Revised MaPP

The FDA published its second revision of “Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters,” MaPP 6020.4 today.

The FDA issues MaPPs to provide instruction to its internal staff on policy and procedure in dealing with various issues.  The document identifies resubmissions to NDAs, BLAs, and efficacy supplements as either Class 1 or Class 2 submissions. 

Biosimilars and Complex Generics Uptake Not as Expected – Why is that a Surprise?

Many articles had decried the fact that biosimilar uptake is not what FDA or the drug industry anticipated.  Look, I have been around in this industry in one form or another (pharmacist, regulator, and consultant) for 46 years and have seen a lot in my day.  They say history repeats itself – no I am not planning to go back to FDA – but the same concepts and forces are in play today as they were when Hatch-Waxman (H-W) was first passed. 

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Have You Heard the News?  Lachman Opens its First European Office

We wanted you to be the first to know.

We at Lachman are very excited to announce our recently opened first European office.  The new office is located in the heart of beautiful Switzerland near Lake Lucerne (Luzern).  This centrally-located European office gives us easier access to our clients in Europe, Asia, and the surrounding regions.

Aloka Srinivasan, Ph.D., New Vice President, Regulatory Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Aloka Srinivasan has accepted the position of Vice President, Regulatory Practice at Lachman Consultants, effective May 14, 2018.

Dr. Srinivasan is a recognized professional with more than 15 years of experience serving at FDA and National Cancer Institute where she contributed to: establishing a DMF review division in FDA to meet GDUFA related goals;