The FDA rapped independent testing lab Valisure in an untitled letter for violating the Drug Supply Chain Security Act (DSCSA) and for “methodological deficiencies” in its testing protocols, disputing the…
The FDA plans to prioritize its enforcement and regulatory actions against specific homeopathic drug categories that pose a significant risk to public health, the agency said in a final guidance.…
A large part of the FDA inspection process is reviewing documents and they need to be accessible promptly on request, an FDA inspections expert advised at the recent WCG FDAnews…
Plaintiffs led by MSP Recovery Claims, a payment recovery firm, have filed a class action lawsuit in federal court alleging Actelion Pharmaceuticals violated the Racketeer Influenced and Corrupt Organizations (RICO) Act by engaging…
In 2021, manufacturers boosted the cost of seven of the country’s most expensive drugs by more than $805 million without any evidence supporting the price hikes, the Institute for Clinical…
A federal judge has decided consumer claims that Zantac (ranitidine) causes cancer were not backed by scientific evidence, and thus several big drugmakers can now avoid thousands of U.S. lawsuits.…
Companies need to know how to access their archives — day or night — when using a third party for document storage and preparing for an FDA inspection, an FDA…
Sponsors of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for cancer can now request approval for intravenous dosing regimens that weren’t included in the…
Summit Therapeutics has acquired licensing rights for Akeso’s ivonescimab, an antibody that targets both programmed cell death receptor 1 (PD-1) and vascular endothelial growth factor (VEGF) in patients with nonsmall-cell…
A new guideline from the International Council for Harmonization (ICH) promotes the use of a continuous manufacturing (CM) process that can lead to shorter production times, a reduced risk of…