Archive for June 2024

In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the deadly side effects of a painkiller. Also, when is an orphan device an orphan? Source: Drug Industry Daily

The FDA issued a complete response letter (CRL) for foscarbidopa/foslevodopa (ABBV-951) based on observations from an inspection at one of AbbVie’s third-party manufacturing facilities, the company announced yesterday. Source: Drug Industry Daily

In a reversal of the previous court’s decision, the US Court of Appeals for the Federal Circuit gave Amarin a win in its fight over Hikma’s generic version of Amarin’s cardiovascular drug Vascepa (icosapent ethyl). Source: Drug Industry Daily

The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining staff, according to a new CDER report. Source: Drug Industry Daily

Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Source: Drug Industry Daily

The FDA is seeking comments on both its information technology (IT) and its customer experience strategies to guide its work and its allocation of budget and resources in the coming year. Source: Drug Industry Daily

Novo Nordisk announced plans to invest $4.1 billion to build a fill and finishing manufacturing facility in North Carolina and grow its ability to produce current and future injectable treatments for people with obesity and other serious chronic diseases. Source: Drug Industry Daily

With FDA’s new regulation of laboratory developed tests (LDT) that becomes effective July 5, the agency has issued a final guidance intended to help small entities comply. Source: Drug Industry Daily

The United States Pharmacopeia (USP) and the FDA are working together to promote opportunities for sponsors to develop new generic medications for off-patent drugs that currently lack an approved generic equivalent. Source: Drug Industry Daily

In this edition of Quick Notes, Akili snags approval for a video game-based ADHD treatment, Johnson & Johnson’s orthopedics unit wins FDA authorization for a partial knee replacement robotic-assist system, Getinge secures 510(k) clearance for clinical decision support software used to improve patient outcomes, and Philips implants the first patient with its Duo Venous stent…