CDRH Director Jeffrey Shuren aims to reverse a historical trend and make the U.S. the top destination for novel medical device launches, improving the center’s efficiency along the way. Source:…
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Source: Drug Industry Daily
Pharmedica USA’s Phoenix, Ariz., drug manufacturing facility was cited by the FDA in a warning letter for lack of a sterile environment for producing its OTC eye drops and for…
FDA Commissioner Robert Califf said Alzheimer’s disease drugs and glucagon-like peptide-1 (GLP-1) agonists for diabetes and obesity could be “major game changers in the ongoing battle with chronic diseases that…
Two draft guidances released by the FDA on Wednesday aim to reduce lag time between approval of a drug for adult use and its subsequent pediatric approval by clarifying requirements…
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be…
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from IVDs and LDTs, developing SOPs and pharmaceutical quality…
Philips Respironics reports risk assessments of its continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) sleep apnea therapy devices showed that degraded sound abatement foam on the…
In a briefing document for an advisory committee meeting this week, the FDA signaled support for Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo (RSVpreF), which has shown to reduce risk…
The Securities and Exchange Commission (SEC) announced Monday that Quanta and two of its top executives have agreed to settle fraud charges brought against the company, stemming from statements the…