FDA CLEARANCE OF BTA STAT FOR PRESCRIPTION HOME USE WOULD EXPAND BARD'S PHYSICIAN MARKET VIA CLIA-WAIVED STATUS; PANEL SUGGESTS SIMPLIFYING LABELING
This article was originally published in The Gray Sheet
Executive SummaryFDA approval of Bard's BTA stat bladder cancer tumor marker assay as a "waived" test under the Clinical Laboratory Improvement Amendments of 1988 would allow greater distribution of the product by opening up the broader physician office market. The agency's Immunology Devices Panel, at its Feb. 2 meeting in Rockville, Maryland, supported prescription home use labeling for the test provided that specific changes designed to simplify the labeling are made.
You may also be interested in...
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.
Consumer health product firms say the coronavirus will have an impact on their results, but it’s too early to estimate the costs. US FDA also hedges its predictions, saying the outbreak could lead to interruptions in country’s drug and medical device supplies. China's health commission has issued six guidelines for diagnosis and treatment, but no conventional antiviral treatment is approved and it's emphasizing traditional Chinese medicines.
With less than one hundred days left before the European Union Medical Device Regulations kick in, Medtech Insight’s executive editor Ashley Yeo and managing editor Amanda Maxwell discuss growing concerns by medtech industry members that they may not be ready in time to comply with these regulations and may inadvertently go afoul of the new regulations.