Uncategorized

13
Mar

Coronavirus Readiness

  As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]

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13
Feb
The Queens Guard

Looking at the Sentinel

FDA has announced the 12th Annual FDA Sentinel Public Workshop on April 20-21, 2020. (Please go here for the details.)  The Sentinel System is the largest multi site patient safety database in the world, and includes the Active Post-marketing Risk Identification and Analysis (ARIA) system mandated by Congress in the US Food and Drug Administration […]

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11
Jul

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live […]

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28
May

USP Chapter <197> Spectroscopy Identification Tests – Controlling Your Identities!

This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]

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28
May

The Numbers Provide Proof of CGT Program

A podcast/article written by LCDR Rinku Patel, Pharm.D., Patent & Exclusivity Team, Office of Generic Drugs Policy, provides a description of the Competitive Generic Therapies program (which we have described previously here and here). Since we have covered the program in detail and there is an FDA draft Guidance available (here), we will not go […]

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28
May

The Treasure Map to Biosimilarity Just Got More Granular

The FDA’s recently published draft guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and other Quality-Related Considerations (here) is a significant improvement over the withdrawn 2012 guidance (i.e., Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product) that it replaced. The increased level of detail and wider breadth of topics gives a […]

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