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Latest Blogs

Particulate Material Back in the News

Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product.  One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station). 

Update on Valsartan “Priority” Review

The FDA’s posting of the approval for the “priority” review ANDA for Valsartan mentioned yesterday (here) occurred today.  The ANDA number was listed as 205536.  It is interesting to note that the ANDA number corresponds to an application that was submitted around the middle of 2013.  That is almost six years! 

FDA Prioritizes ANDA for Valsartan to Avert Shortage

On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.”  The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.

Compounder of Sterile Products Hit with Consent Decree

A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas.  According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products.  “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.  

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Tim Rhines, Ph.D., Joins Lachman Consultants as a Director in the Science and Technology Practice

Timothy Rhines, Ph.D. is a Director in the Science & Technology Practice at Lachman Consultants who is a seasoned CMC pharmaceutical / biopharmaceutical professional with more than 27 years directing CMC activities, leading analytical chemistry teams, addressing compliance gaps, compliance department leadership with P&L responsibility, implementing process excellence initiatives, developing pharmaceutical product stability operations, and CMC project management.

Lachman Consultants to Offer Insights on Future Transition of Biological Products at the 2019 Parenteral Drug Association (PDA) Annual Meeting

(Westbury, NY – February 2019) Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs and technical services to life sciences organizations worldwide will be a Bronze Sponsor at the 2019 Annual Meeting of the Parenteral Drug Association (PDA), Booth #308, March 11-13, at the Marriott Marquis San Diego, San Diego, CA. Themed “Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products,” the PDA’s flagship Annual Meeting provides a venue for obtaining the latest information on parenteral processing,