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Latest Blogs

Office of Generic Drugs Updates First Generic Approvals List for 2019

Today, OGD updated its first generic approvals list (here).  So far this calendar year, OGD reports 43 first generic approvals through April 26, 2019.  The FDA notes:

“First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.  

Generics and the News – Bad Start to the Week or Just Business as Usual?

From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week.  The report on price fixing was met with a response to 60 Minutes May 12,

April 2019 Approval Actions, Receipts, and Complete Responses Posted

Today, FDA posted the official ANDA approval actions and receipts for April 2019.  While the All Approval list reported 93 full ANDA approval actions and 15 tentative approval actions for ANDAs, when we wrote our first blog estimating the approval actions for April on May 3rd  (here) ,   the official FDA numbers for April reported for approval actions was 98 and tentative approval actions was 18,

A Deeper Dive on the Biosimilar Interchangeability Guidance Viewed from Our Biologics Expert

On Friday May 10, the FDA published the much-anticipated final version of the guidance document Considerations in Demonstrating Interchangeability with a Reference Product.  We did a general post here  and, while recognizing the final version is similar (highly similar?) to the previous draft from January 2017, a careful review (as outlined here) found several useful and potentially significant changes in the final guidance.

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Accomplished Global Pharma Executive Mary Oates Joins Lachman Consultants, Inc. as VP of Compliance Services

(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,

Lachman Consultants Returns to ISPE Europe 2019

(Westbury, NY – March 2019) On the heels of establishing a European based presence last year, Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the ISPE Europe 2019 Annual Conference. Lachman is sponsoring the event on April 1-4,