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TXT FDA Releases EIR of Troubled Revance Facility [378 Words] [ Price : $8.95]
FDA releases the Establishment Inspection Report associated with a complete response letter issued to Revance Therapeutics on its BLA for daxibotulinumtoxinA for injection and its use in treating moderate to severe glabellar (frown) lines.
11/19/2021
 
 
TXT Hep C Tests Down Classified to Class 2 510(k) [125 Words] [ Price : $8.95]
FDA issues two final orders reclassifying certain Hepatitis C virus diagnostic tests from Class 3 to Class 2.
11/19/2021
 
 
TXT Information Collection on Device Detentions [71 Words] [ Price : $8.95]
Federal Register: FDA seeks comments on an information collection extension entitled “Administrative Detention and Banned Medical Devices.”
11/19/2021
 
 
TXT CDRH FY 2022 Guidance Development Correction [66 Words] [ Price : $8.95]
Federal Register notice: FDA corrects a 10/27 notice identifying the Web site where to find CDRH’s fiscal year 2022 proposed guidance development.
11/19/2021
 
 
TXT Boosters Permitted for Individuals Aged 18 Years and Older [118 Words] [ Price : $8.95]
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 years of age and older.
11/19/2021
 
 
TXT FDA Article Examines ENFit Syringe Dosing Errors [361 Words] [ Price : $8.95]
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 syringes.
11/19/2021
 
 
TXT Former FDA Top Lawyer Hails RWE Advances [714 Words] [ Price : $8.95]
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 evidence at FDA.
11/19/2021
 
 
TXT Biomarin’s Short Stature Drug Accelerated Approval [168 Words] [ Price : $8.95]
FDA grants BioMarin accelerated approval for Voxzogo (vosoritide) for injection, indicated to increase linear growth in pediatric patients with achondroplasia, the most common form of disproportionate short stature.
11/19/2021
 
 
TXT Regulatory Review Period for Sunosi [91 Words] [ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Jazz Pharmaceuticals’ Sunosi (solriamfetol Hcl).
11/18/2021
 
 
TXT Info Collection on Generic Drug User Fees [59 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled “Generic Drug User Fee Program.”
11/18/2021
 
 
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