Lachman Consultant Services, Inc. / Articles by: Rebecca Welton
01
Feb

CARES Act Manufacturing Quantities Reporting Requirement – Better Sharpen Your Pencils!

By    Feb 01, 2022    CARES Act Compliance FDA Generics NDA OTC Regulatory Affairs

Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference.  This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]

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05
Feb

Safety Trial Finds Increased Risk of Serious Heart-Related Problems and Cancer with Xeljanz, Xeljanz XR (tofacitinib)

By    Feb 05, 2021    FDA NDA Regulatory Affairs Safety

When FDA approved the Pfizer drug product tofacitinib (Xeljanz, Xeljanz XR), which treats arthritis and ulcerative colitis by decreasing the activity of the immune system, they required that Pfizer conduct post-approval safety trials to evaluate the risk of serious heart-related events, cancer and infections. Tofacitinib is offered in two strengths which were both studied in […]

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