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TXT Latest Federal Register Notices [2880 Words] [ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 4/22/2022.
04/24/2022
 
 
TXT Covid-19 Vaccine Guidance Update [71 Words] [ Price : $8.95]
Federal Register notice: FDA makes available an updated guidance document entitled Emergency Use Authorization for Vaccines to Prevent Covid–19 (Updated 3/31).
04/22/2022
 
 
TXT Guide on 510(k) Refuse to Accept Policy [118 Words] [ Price : $8.95]
FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency intends to use in assessing whether a medical device 510(k) submission should be accepted for substantive review.
04/22/2022
 
 
TXT Biogen Pulls European Submission on Alzheimer’s Drug [393 Words] [ Price : $8.95]
Biogen withdraws a European marketing authorization application for its troubled Alzheimer’s drug aducanumab.
04/22/2022
 
 
TXT Revance BLA Resubmission Accepted for Review [449 Words] [ Price : $8.95]
FDA accepts for review a Revance Therapeutics BLA resubmission for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, following a 10/2021 Complete Response Letter.
04/22/2022
 
 
TXT FDA Nixes 6 Outdated Compliance Policy Guides [157 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative information or they no longer reflects the agency’s current thinking.
04/22/2022
 
 
TXT Comments Sought on Electronic Drug Quality Data Submissions [223 Words] [ Price : $8.95]
FDA seeks comments from the pharmaceutical industry on its project to identify and prioritize pharmaceutical quality and chemistry and manufacturing and controls information that would benefit from a structured electronic submission approach.
04/22/2022
 
 
TXT Guide on Nanomaterial in Drugs/Biologics [67 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials.
04/22/2022
 
 
TXT Guidance on N-Acetyl-L-Cysteine Policy [72 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.
04/22/2022
 
 
TXT Device RWE Partnership [2656 Words] [ Price : $8.95]
The National Evaluation System for Health Technology Coordinating Center is partnering with Aetion on a five-year strategic effort to advance the use of real-world evidence in medical devices and diagnostics.
04/21/2022
 
 
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