Aldeyra Therapeutics on Monday announced receipt of an FDA complete response letter (CRL) for the NDA of reproxalap, for the treatment of dry eye disease, asking the company to conduct…
Sponsors of drugs being developed to treat or prevent COVID-19 should consider the importance of enrolling older adults, including those 75 and older, in drug trials and even consider running…
This edition of Quick Notes highlights an ITC decision to investigate Lilly’s claims of Mounjaro trademark infringement, an FDA motion to dismiss an SCA pharmaceuticals lawsuit and AbbVie’s lawsuit against…
A new eligibility checker for the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) International Recognition Procedure (IRP) has gone live, enabling drugmakers to determine if their drug will be…
The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily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:…