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FDA Releases EIR of Troubled Revance Facility
[378 Words]
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| 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. |
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11/19/2021
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Information Collection on Device Detentions
[71 Words]
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| Federal Register: FDA seeks comments on an information collection extension entitled “Administrative Detention and Banned Medical Devices.” |
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11/19/2021
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CDRH FY 2022 Guidance Development Correction
[66 Words]
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| Federal Register notice: FDA corrects a 10/27 notice identifying the Web site where to find CDRH’s fiscal year 2022 proposed guidance development. |
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11/19/2021
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FDA Article Examines ENFit Syringe Dosing Errors
[361 Words]
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| 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. |
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11/19/2021
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Former FDA Top Lawyer Hails RWE Advances
[714 Words]
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| 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. |
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11/19/2021
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Biomarin’s Short Stature Drug Accelerated Approval
[168 Words]
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| 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. |
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11/19/2021
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Regulatory Review Period for Sunosi
[91 Words]
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| Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Jazz Pharmaceuticals’ Sunosi (solriamfetol Hcl). |
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11/18/2021
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Info Collection on Generic Drug User Fees
[59 Words]
[ Price : $8.95]
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| Federal Register notice: FDA seeks comments on an information collection extension entitled “Generic Drug User Fee Program.” |
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11/18/2021
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