FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 11/19/2021.
Medical Devices
Hep C Tests Down Classified to Class 2 510(k)
FDA issues two final orders reclassifying certain Hepatitis C virus diagnostic tests from Class 3 to Class 2.
Federal Register
Information Collection on Device Detentions
Federal Register: FDA seeks comments on an information collection extension entitled Administrative Detention and Banned Medical Devices.
Federal Register
CDRH FY 2022 Guidance Development Correction
Federal Register notice: FDA corrects a 10/27 notice identifying the Web site where to find CDRHs fiscal year 2022 proposed guidance development.
Human Drugs
Boosters Permitted for Individuals Aged 18 Years and Older
FDA amends the emergency use authorizations for both the Moderna and Pfizer-BioNTech Covid-19 vaccines to allow a booster dose for all individuals 18 ...
Medical Devices
FDA Article Examines ENFit Syringe Dosing Errors
CDRH says a recent journal article sheds some light on an agency safety alert about the risk of medication overdose from the moat area of ENFit LDT sy...
FDA General
Former FDA Top Lawyer Hails RWE Advances
Former FDA chief counsel Stacy Cline Amin says the Covid-19 emergency has been the single greatest catalyst for advancing the use of real-world eviden...
Biologics
Biomarins Short Stature Drug Accelerated Approval
FDA grants BioMarin accelerated approval for Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achond...
Human Drugs
FDA Releases EIR of Troubled Revance Facility
FDA releases the Establishment Inspection Report associated with a complete response letter issued to Revance Therapeutics on its BLA for daxibotulinu...
