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TXT Latest Federal Register Notices [1265 Words] [ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 11/20/2020.
11/22/2020
 
 
TXT Draft Guide on Device Electromagnetic Compatibility [66 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.
11/17/2020
 
 
TXT Adding CDK Inhibitors Helps Some Breast Cancer Treatment: Study [2700 Words] [ Price : $8.95]
CDER researchers say adding a CDK 4/6 inhibitor to hormonal treatment helps some metastatic breast cancer patients.
11/17/2020
 
 
TXT Workshop on Generic Peptide Product Immunogenicity Risks [256 Words] [ Price : $8.95]
FDA announces a 1/26 virtual workshop on non-clinical assays for comparative immunogenicity risk assessment for generic peptide products.
11/17/2020
 
 
TXT Hahn Says FDA Increasing EUA Transparency [2875 Words] [ Price : $8.95]
FDA commissioner Stephen Hahn says the agency is posting scientific review materials relating to emergency use authorization actions taken by FDA, as recommended in a GAO report.
11/17/2020
 
 
TXT PhRMA Adds Diversity to Clinical Trial Principles [2647 Words] [ Price : $8.95]
PhRMA adds a chapter on diversity to its principles for conducting and communicating clinical trials.
11/17/2020
 
 
TXT Safety-Related Labeling Changes Posted [2605 Words] [ Price : $8.95]
FDA posts new drug safety-related labeling changes for five biologics.
11/17/2020
 
 
TXT Multiple Violations at Family Pharmacy of Statesville [2855 Words] [ Price : $8.95]
FDA warns Family Pharmacy of Statesville, NC, about multiple drug compounding violations.
11/17/2020
 
 
TXT Certificates of Confidentiality Final Guidance [258 Words] [ Price : $8.95]
FDA issues a final guidance on Certificates of Confidentiality, which describes the agency’s implementation of revised provisions under the 21st Century Cures Act.
11/17/2020
 
 
TXT FDA Complete Response Letter for Alkermes Psych Drug [2716 Words] [ Price : $8.95]
Alkermes says it is working with FDA on issues raised in an agency complete response letter for the firm’s NDA for ALKS 3831 to treat schizophrenia and bipolar disorder 1 in adults.
11/17/2020
 
 
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