We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Read More
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
The FDA hit Florida stem-cell supplier RichSource Stem Cells with an untitled letter for unapproved claims relating to its RICHGEN stem cell product.
Read More
In a move to help sponsors of insulin biosimilar applications, the FDA spelled out the data and information needed to support immunogenicity assessments for insulin biosimilars or interchangeables in a draft guidance released on Monday.
Read More
The Australian Therapeutic Goods Administration (TGA) has released updated guidance on the testing of biological drugs to reflect its most current practices. Read More
Otsuka and H. Lundbeck expect to launch once-daily Rexulti as a treatment for schizophrenia and add-on therapy for major depressive disorder in early August, following FDA approval Monday. Read More
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. Read More
The European Medicines Agency has chosen six drugs for initial review under its adaptive pathways pilot project, out of 34 potential candidates. Read More