European Pharmaceutical Review
AUGUST 23, 2022
A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.
Eye on FDA
JUNE 14, 2023
The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). It was the second letter for this company, the first having been issued in August, 2020 for a TV advertisement. Of those without boxed warnings (9 in number), only 2 had Warning Letters.
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pharmaphorum
APRIL 9, 2021
The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.
pharmaphorum
AUGUST 9, 2021
In 2010, Lumizyme’s label was expanded to the under-right group as well. Myozyme was first to market in 2006 for infantile-onset Pompe, with Lumizyme reaching the market four years later to treat late-onset Pompe in children aged over eight.
European Pharmaceutical Review
NOVEMBER 10, 2022
Based on fluorescently labelled antibodies and drugs, the technology offers an array of benefits to drug discovery, from characterising complex cell models of disease to understanding the molecular mechanism of drug action. J Cell Sci (2010) 123 (8): 1183–1189. Figure 2 ). Ex vivo tissue analysis. J Multidiscip Healthc. Gunnarsson, A.,
Pharmaceutical Technology
OCTOBER 5, 2022
In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial.
Eye on FDA
AUGUST 2, 2022
By 2002, the number had dropped to 28, reviving somewhat by the end of that decade when it reached 52 in 2010. But when it comes to enforcement things have changed greatly over the years. In 1998, there were 156 letters issued in a single year. So far this year, we are at 4, which is a pretty good clip these days.
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