Posts by PacConAdmin

In this edition of Quick Notes, the FDA has elevated four device recalls to Class I, including an infusion pump that has caused six injuries and one death, two PCB-leaching brands of dialysis tubing, and an anesthesia machine that might simply shut off if used on battery power. Source: Drug Industry Daily

This week, the European Parliament adopted the European Commission’s (EC) proposal to grant more time for companies to come into compliance with 2022’s In Vitro Diagnostic Medical Devices Regulation (IVDR). Source: Drug Industry Daily

Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made by Chinese manufacturer Jiangsu Shenli Medical Production. Source: Drug Industry Daily

This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Source: Drug Industry Daily

Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements needed for NDAs and ANDAs. Source: Drug Industry Daily

In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder cancer, a generic form of Narcan nasal spray, and a pediatric version of Lutahera — the first-ever radioligand approved for use in children. Source: Drug Industry Daily

A Senate committee has demanded answers from Danish pharma Novo Nordisk on what it labels “astronomically” high prices for the company’s Ozempic/Wegovy (semaglutide) diabetes/weight loss drugs, while a report points to weight loss drugs as the driver for a massive spike in drug spending. Source: Drug Industry Daily

The FDA is soliciting input from interested parties on policy topics the CDER Office of Clinical Pharmacology (OCP) could develop and implement to support drug development programs. Source: Drug Industry Daily

Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of cable connection failure and software defects. Source: Drug Industry Daily

Most postmarketing requirements (PMR) and postmarketing commitments (PMC) for NDAs and BLAs were on-schedule in 2022, according to figures just released by the FDA. Source: Drug Industry Daily