Establishing greater industry agility in quality management requires increased technical harmonization and regulatory convergence among global health agencies, says Theresa Mullin, associate director for strategic initiatives with CDER. Source: Drug…
Abiomed received a warning letter for its Impella Connect System for failing to have an approved application for premarket approval or an investigational device exemption, according to the FDA’s warning…
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from…
The FDA has created the new Digital Health Advisory Committee to help the agency explore the complex issues related to artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics,…
Most predictive clinical decision support devices (CDS) that rely on machine learning (ML) or AI are approved and marketed without adequate proof that they deliver on their promise of improving…
A district court has handed a preliminary injunction to EOFlow, blocking it from selling products developed using proprietary information derived from insulin pump maker Insulet — the decision arriving as…
HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first…
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Source: Drug Industry Daily
Pfizer announced that the FDA has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab), giving pharmacists the ability to substitute it for Humira without intervention from the prescribing…
The FDA has revised the Manual of Policies and Procedures (MAPP) for ANDA assessment practices with changes intended to decrease the number of review cycles needed for approval. Source: Drug…