Archive for November 2023

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

UK-based medical devicemaker LivaNova reported that it detected disruption of portions of its information technology systems as a result of a cybersecurity incident. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily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). Source: Drug Industry Daily

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. Source: Drug Industry Daily