The Lachman Blog

07
Dec

Just in Case You Couldn’t Attend – The Lachman Learning Experience Data Integrity Webinar

Data integrity is an ever-increasing concern in the life sciences as evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry. To help manufacturers better understand, establish, and maintain data integrity under growing regulatory scrutiny, Lachman Consultant Services, Inc. (Lachman Consultants) hosted a free webinar on Wednesday, […]

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06
Dec

New Dissolution Method for Long-Acting Injectable Suspensions May Provide Better Data

FDA and industry have long wrestled with appropriate dissolution methodology for injectable suspension products. Investigations into the relevance of the dissolution methods utilized has shown wide variation in in vivo results despite consistent in vitro performance. As FDA notes in a recent  article (here) on the new potential improved method developed to address “gaps between […]

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18
Nov

November FY 22 Mid-Month Generic Approval Outlook and Final October Official Approvals

Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions. November has at least […]

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16
Nov

AAM All Access Podcast Special Featuring Bob Pollock Now Available!

Last week, Lachman hosted a virtual booth at the GRx+Biosims 2021 interactive event, where we engaged in a series of dynamic discussions around issues, trends, and challenges vital to the generic and biosimilar medicines industry. The three-day event also featured a podcast special with AAM CEO Dan Leonard and Lachman Senior Advisor Bob Pollock. The […]

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11
Nov

Data Integrity Webinar – Manufacturing & Quality – A Lachman Learning Experience

Data integrity is an ever-increasing concern in life sciences evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry, for the purpose of ensuring safety, and enhancing quality among all manufacturers. Coming under recent scrutiny in the area is data integrity and its far-reaching impact on manufacturing […]

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