CDRH ASCA team member Angela DeMarco says the ASCA pilot program is on schedule with 53 test labs accredited.
FDA grants a de novo marketing authorization request to Cognoa for its Cognoa ASD Diagnosis Aid to help diagnose autism spectrum disorder.
Researchers say that atrial fibrillation patients who use smartwatches or other wearable devices to manage their condition make greater follow-up use ...
FDA says 97 medical device manufacturers may be affected by sterility issues at the now-closed Steril Milano ethylene oxide sterilization facilities i...
FDA approves a Scynexis NDA for Brexafemme (ibrexafungerp) tablets for oral use in patients with a vaginal yeast infection.
The Council for Responsible Nutrition says FDA should revert to its prior policy allowing NAC to be sold as a dietary supplement.
FDA acting commissioner Janet Woodcock says biosimilar product development is maturing with the help of numerous initiatives at the agency.
FDA warns Utah Cord Bank about significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products.