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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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Latest Blogs

FDA Is Eliminating Regulations? Here’s One that Makes Sense!

The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA.  The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777.  Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal,

August Official Approvals and Receipts Released as OGD Approaches Record Year

The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday.  August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017.  These approvals are quite an accomplishment given the fact that the slowdown in the first few months of calendar year 2018 was so drastic.

No Easy Solutions for Complex Generics Yet

The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018.  In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,

Reduced Testing, but Not Reduced Expectations

Reduced testing of Active Pharmaceutical Ingredients (API), excipients, and other raw materials can be a valid approach to gaining overall efficiencies in the pharmaceutical quality control laboratory.  However, the choice of tests to perform and the justification for choosing those tests are key elements of operating a compliant Reduced Testing Program that is also scientifically sound.

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Visit Lachman Consultants at Booth 13/14 at AAM GRx + Biosims!

While you are attending the AAM GRx + Biosims meeting September 5-7, 2018 at the Hilton Baltimore, please be sure to visit Lachman Consultant Services at booth 13/14 and drop your business card for a chance to win an iPad 9.7 and Apple pen! As they say, you’ve got to be in it to win it!

Fran Zipp, CEO and President of LCS, to Moderate Panel at AAM GRx + Biosims Conference

On September 5, 2018, at 1:30 PM, Lachman Consultant Services’ CEO and President and CEO will be moderating a panel on Data Integrity at the AAM GRx + Biosims meeting. Ms. Zipp will be joined by Derek Glover (Head of Global Quality Systems and Compliance, Mylan Pharmaceuticals Inc.), Sarah Barkow, Ph.D. (Lead Consumer Safety Officer,