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, […]
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 […]
Well, OGD is back over the 70 mark for total number of approval actions in a single month, with what appear to be at least 72-66 full approval actions and six (6) tentative approval actions reported, going by the numbers posted at 11 AM EST December 3 on FDA’s website. The last time OGD had […]
FDA has released its revised outline of specific generic drug research priorities for FY 2022 (see here) based on feedback of stakeholders in a public meeting held on June 23, 2021 as well as written comments received on the 15 proposed research priorities announced at that meeting and the issues that FDA sought comments on […]
Here we are, another Thanksgiving almost in the books, and reading the newspaper or listening to the news makes one wonder what we have to be thankful for. Then an old Bing Crosby song comes to mind… “You’ve got to ac-cent-u-ate the positive, e-lim-in-ate the negative. Latch on to the affirmative. Don’t mess with Mister […]
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 […]
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 […]
In a news release on November 15th (here), the FDA announced that ”the U.S. Department of Health and Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). This action will help ensure that COVID-19 tests are accurate and reliable.” The Trump policy was a misguided […]
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 […]
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 […]
