The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily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…
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…
The lot size doesn’t really matter when it comes to choosing a sample size for a pharmaceutical or medical device, says sampling expert Steven Walfish. Source: Drug Industry Daily
Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial…
Continued efforts to obtain approval for a drug to treat a rare neuromuscular disorder appear in this month’s Research Roundup along with an oral anticoagulant, and treatments for peanut allergy…
This edition of Quick Notes highlights a major supplier’s data breach, good news for wearable defibrillator and renal denervation devices, and labeling to remind surgeons about nonapproved mesh products. Source:…
Nearly half of rare oncology drug approvals include postmarketing requirements (PMR) for drug-drug interactions (DDI), a particular concern for cancer patients who are frequently being treated for co-morbidities and palliative…
In this edition of Quick Notes, we review recent FDA drug approvals of combination drug Truqap/Faslodex for breast cancer, DefenCath for hemodialysis patients, non-small cell lung cancer treatment Augtyro, a…
The FTC has filed an amicus brief amid the ongoing dispute between Viatris’ Mylan and Sanofi over the latter’s patents for Lantus insulin, assailing the use of improperly listed Orange…
The first systematic review using statistical methods to look at the risk of switching patients from reference biologics to a biosimilar, or the other way around, found no difference in…