FDA Webview posts the following Federal Register notices that published during our annual holiday break (12/20-12/30).
FDA warns Chinas Global Medical Production about Quality System and Medical Device Reporting violations in its production of medical devices.
FDA warns Chinas Guangzhou Shiruoni Cosmetics Co. about adulterated and misbranded Impacta hand sanitizer that was marketed in the U.S.
Janssen asks FDA to approve its teclistamab for some multiple myeloma patients.
FDA warns Chinas Guangdong Kemei Pharmaceutical Technology Co. it is marketing an unapproved, adulterated, and misbranded hand sanitizer.
FDA issues a draft guidance on technical considerations for medical devices with physiologic closed-loop control technology.
FDA warns Medtronic about Quality System and Medical Device Reporting violations at its Northridge, CA, manufacturing facility.
FDA issues a draft guidance on assessing the credibility of computational modeling and simulation in medical device submissions.