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Welcome to FDAweb Pay Per View Search our 72,047 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Next >>   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     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     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     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     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treating moderate to severe glabellar lines, following a 10/2021 Complete Response Letter. 04/22/2022     FDA Nixes 6 Outdated Compliance Policy Guides [157 Words] [ Price : $8.95] Federal Register notice: FDA withdraws six compliance policy guides because they contain duplicative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     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     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     Guidance on N-Acetyl-L-Cysteine Policy [72 Words] [ Price : $8.95] Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine. 04/22/2022     Device RWE Partnership [2656 Words] [ Price : $8.95] The National Evaluation System for Health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     << Prev  8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27  Next >>

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