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After receiving reports of T-cell malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies, the agency has announced an investigation into the issue and is evaluating the need for regulatory action. Read More
This edition of Quick Notes highlights recalls for Excela sodium bicarbonate, sodium chloride and cysteine hydrochloride, Novartis cyclosporin, Bayer larotrectinib, Unomedical VariSoft infusion sets and SoClean CPAP cleaner. Read More
FDA investigators found that visual inspectors manipulated particle and defect counts to keep finished products within rejection limits in a May 1-12 inspection of Intas Pharmaceuticals’ Ahmedabad facility, earning the company a warning letter and import alert. Read More
UK-based medical devicemaker LivaNova reported that it detected disruption of portions of its information technology systems as a result of a cybersecurity incident. Read More
The troubled U.S. drug supply chain remains in the spotlight with President Biden announcing nearly 30 new actions to help bolster supply chain resilience, including convening a new White House council focused on the issue and deploying the Defense Production Act to bolster U.S. manufacturers’ ability to make more essential medicines. Read More
Aldeyra Therapeutics on Monday announced receipt of an FDA complete response letter (CRL) for the NDA of reproxalap, for the treatment of dry eye disease, asking the company to conduct an additional trial to show the efficacy of the drug. Read More
Sponsors of drugs being developed to treat or prevent COVID-19 should consider the importance of enrolling older adults, including those 75 and older, in drug trials and even consider running trials in nursing homes and other facilities that care for the elderly, the agency advises in a straight-to-final guidance. Read More
This edition of Quick Notes highlights an ITC decision to investigate Lilly’s claims of Mounjaro trademark infringement, an FDA motion to dismiss an SCA pharmaceuticals lawsuit and AbbVie’s lawsuit against five generics makers for potentially violating Rinvoq patents. Read More
A new eligibility checker for the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP) has gone live, enabling drugmakers to determine if their drug will be eligible to use other countries’ regulatory approvals to speed MHRA acceptance. Read More
The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The lot size doesn’t really matter when it comes to choosing a sample size for a pharmaceutical or medical device, says sampling expert Steven Walfish. Read More