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FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration's Fight Against Pandemic
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COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
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3
Emily Miller and Another PR Expert Ousted At FDA After Blood Plasma Fiasco
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Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020
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Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
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Coronavirus (COVID-19) Update: Daily Roundup September 16, 2020
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The FDA's Oversight of Vaccines is Vital to Public Health
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Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020
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9
FDA Warns Website Operators Illegally Selling Opioids to Consumers
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COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
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11
FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations
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12
FDA approves new drug application for phosphorus drug
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FDA identifies which molecular diagnostic COVID tests provide best results
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14
Coronavirus (COVID-19) Update: Daily Roundup September 14, 2020
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15
During coronavirus vaccine development, medical groups urge FDA to 'maintain transparency'
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FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
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PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower
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FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
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19
DTx regulatory teams talk the power of research beyond ticking FDA's boxes
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20
FDA accepts avacopan NDA for ANCA-associated vasculitis
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Coronavirus (COVID-19) Update: Daily Roundup September 11, 2020
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22
185 hand sanitizers recalled after reports of blindness and hospitalizations, FDA report
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23
Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma
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24
Illinois Food Processor Receives Injunction From FDA
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25
New FDA Approval for HIV Treatment (FCL Sept. 18)
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Latest Update on FDA’s Software Pre-Cert Pilot Program
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FDA ranks the performance of 58 molecular coronavirus tests from major developers
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FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
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29
Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents :: Pink
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30
National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
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31
FDA to Review Avacopan for ANCA-Associated Vasculitis
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Coronavirus (COVID-19) Update: Daily Roundup September 9, 2020
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FDA issues first injunction under Produce Safety Rule
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34
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
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35
Medimetriks' MM36 (difamilast) Atopic Dermatitis Development Program Streamlined Following FDA Meeting
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36
How to assess symptoms in COVID-19 trials: new FDA guidance
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37
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
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38
Nearly 60 coronavirus tests undergo performance checks by FDA
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39
Coronavirus (COVID-19) Update: Daily Roundup September 1, 2020
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40
First Ever FDA-Approved Treatment for Peanut Allergy Now Available
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41
Silicon Valley startup Visby's portable COVID-19 test gets FDA approval
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42
Intelligent Ultrasound submits FDA filing for AI software
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43
FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta
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44
Microbiome startup raises $90M as it prepares for a potential FDA first
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45
FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
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Coronavirus (COVID-19) Update: Daily Roundup August 19, 2020
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Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
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Sorrento Surges On FDA Nod For Initiating Clinical Study Of COVID-19 Antibody Treatment
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Coronavirus (COVID-19) Update: Daily Roundup August 31, 2020
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50
FDA injunction forces sprout grower to stop production
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Senior FDA career executives: We're following the science to protect public health in pandemic
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Visby's portable COVID-19 test gets FDA approval
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Coronavirus (COVID-19) Update: Daily Roundup August 25, 2020
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54
Ophthalmic organizations request FDA reconsider moxifloxacin removal from 503B bulk list
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55
ACE Medical Company Receives 510(k) Approval from the FDA
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Federal government announces vaccines will be FDA approved soon
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How the FDA should protect its integrity from politics
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Bill Gates says the FDA lost credibility during pandemic
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59
AstraZeneca COVID-19 trial on hold in US as FDA investigates UK participant's serious illness
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60
Hey FDA, hands off my fitness tracker | TheHill
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The FDA's new app for frontline doctors could help discover Covid-19 treatments faster
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62
FDA registration renewal deadline looming for US food and feed facilities
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63
Trump’s political meddling in the CDC and FDA is downright dangerous
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Coronavirus (COVID-19) Update: Daily Roundup August 24, 2020
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FDA: No proof of Covid transmission from food – The Manila Times
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HHS chief overrode FDA officials to ease testing rules
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FDA leader says agency could consider authorization for Covid-19 vaccine before Phase 3 trials are complete, Financial Times reports
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Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
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Trump has launched an all-out attack on the FDA. Will its integrity survive?
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70
Rhenium NanoLiposomes receives Fast Track Designation from FDA for glioblastoma treatment
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Cadila Healthcare gains 6% on US FDA nod for mineral supplement
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FDA Proposes Reclassification of Cytomegalovirus Quantitative Tests
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73
Quadphasic Synthetic Bone Graft Cleared by FDA
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Import Screening Pilot Unleashes the Power of Data
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Riot Lab's first-round PMTA applications accepted by FDA
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76
Prima® Wawona Recalls Bagged Peaches Due to Possible Salmonella Risk
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CorgioMed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL
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Popular liver spread included in FDA list of unregistered food products, supplements
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2 Korean Companies Share 3rd Place in FDA's Evaluation of COVID-19 Diagnostic Kits
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In FDA's green light for treating COVID-19 with plasma, critics see thin evidence—and politics
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81
American College of Radiology among dozens urging FDA to exercise caution in approving COVID-19 vaccine
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Accelerate Diagnostics Announces New FDA Clearance for Accelerate PhenoTest® Improvements
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83
Fitbit’s Sense smartwatch gets FDA clearance for EKG app
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Sunshine Mills, Inc. Issues Voluntary Recall of Certain Dog Food Products Due to Potentially Elevated Levels of Aflatoxin
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85
On COVID, politics infects science at the CDC and the FDA
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86
FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework
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Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early
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Coronavirus (COVID-19) Update: Daily Roundup August 21, 2020
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Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels
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Roche Granted FDA Emergency Use Authorization for Cobas SARS-CoV-2 & Influenza A/B Test
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91
Investigational Myeloma Treatment KP1237 Wins FDA Orphan Drug Status
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FDA Publishes First Batch of SARS-CoV-2 MDx Limit of Detection Comparison Results
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93
Second Trump appointee out at FDA amid credibility concerns
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Equilibrium Inc. (NASDAQ:EQ) Receives Positive Feedback From the FDA On Itolizimab Treating Hospitalized COVID-19 Patients
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In a 'Lethal' Pandemic, FDA Has to Weigh Vaccine Risks With How Many Lives Could Be Saved, Commissioner Says
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FDA weighs whether to resume AstraZeneca vaccine trials after patient's serious side effect
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Roche gets FDA nod for faster combo coronavirus-flu test
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CCXI To Face FDA In April, CRDF Soars On Colorectal Cancer Trial Data, VCNX In Deal With MRK
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Sunshine Mills, Inc. Issues Voluntary Recall of Nature's Menu® Super Premium Dog Food with a Blend of Real Chicken & Quail Because of Possible Salmonella Health Risk
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100
Trump Administration Says Some Coronavirus Tests Can Bypass F.D.A. Scrutiny
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