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Our blogs feature and report on the latest news and trends in the industry.
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Latest Blogs

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. 

After an Anemic Start, First Time Generics for the Year Take a Jump in July

First-time generic approvals are always good for the public and the industry.  Through June, there were only 34 first approvals for the calendar year (an average of about 5.6 a month) and it looked like 2018 was going to be a slow year.  Then came the July first‑time approval postings (here),

OMG! OGD Shatters ANDA Approval Actions for July – and More!

While we reported that July had already broken the previous approval record prior to the official July numbers being posted in an earlier post (here) we were happily shocked when the official approval numbers came out today (here).  OGD fully approved a record 96 ANDAs (previous record was 88 in June FY 2017) and tentatively approved 30 ANDAs (previous record was 23 in November 2017 (also in FY 2018) for a total 126 approval actions!

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Latest News

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;