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1 FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration's Fight Against Pandemic
2 COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
3 Emily Miller and Another PR Expert Ousted At FDA After Blood Plasma Fiasco
4 Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020
5 Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
6 Coronavirus (COVID-19) Update: Daily Roundup September 16, 2020
7 The FDA's Oversight of Vaccines is Vital to Public Health
8 Coronavirus (COVID-19) Update: Daily Roundup September 15, 2020
9 FDA Warns Website Operators Illegally Selling Opioids to Consumers
10 COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
11 FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations
12 FDA approves new drug application for phosphorus drug
13 FDA identifies which molecular diagnostic COVID tests provide best results
14 Coronavirus (COVID-19) Update: Daily Roundup September 14, 2020
15 During coronavirus vaccine development, medical groups urge FDA to 'maintain transparency'
16 FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
17 PerkinElmer tops FDA COVID-19 test sensitivity list, with BD and Roche scoring lower
18 FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
19 DTx regulatory teams talk the power of research beyond ticking FDA's boxes
20 FDA accepts avacopan NDA for ANCA-associated vasculitis
21 Coronavirus (COVID-19) Update: Daily Roundup September 11, 2020
22 185 hand sanitizers recalled after reports of blindness and hospitalizations, FDA report
23 Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma
24 Illinois Food Processor Receives Injunction From FDA
25 New FDA Approval for HIV Treatment (FCL Sept. 18)
26 Latest Update on FDA’s Software Pre-Cert Pilot Program
27 FDA ranks the performance of 58 molecular coronavirus tests from major developers
28 FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
29 Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents :: Pink
30 National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
31 FDA to Review Avacopan for ANCA-Associated Vasculitis
32 Coronavirus (COVID-19) Update: Daily Roundup September 9, 2020
33 FDA issues first injunction under Produce Safety Rule
34 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
35 Medimetriks' MM36 (difamilast) Atopic Dermatitis Development Program Streamlined Following FDA Meeting
36 How to assess symptoms in COVID-19 trials: new FDA guidance
37 Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency
38 Nearly 60 coronavirus tests undergo performance checks by FDA
39 Coronavirus (COVID-19) Update: Daily Roundup September 1, 2020
40 First Ever FDA-Approved Treatment for Peanut Allergy Now Available
41 Silicon Valley startup Visby's portable COVID-19 test gets FDA approval
42 Intelligent Ultrasound submits FDA filing for AI software
43 FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta
44 Microbiome startup raises $90M as it prepares for a potential FDA first
45 FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
46 Coronavirus (COVID-19) Update: Daily Roundup August 19, 2020
47 Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
48 Sorrento Surges On FDA Nod For Initiating Clinical Study Of COVID-19 Antibody Treatment
49 Coronavirus (COVID-19) Update: Daily Roundup August 31, 2020
50 FDA injunction forces sprout grower to stop production
51 Senior FDA career executives: We're following the science to protect public health in pandemic
52 Visby's portable COVID-19 test gets FDA approval
53 Coronavirus (COVID-19) Update: Daily Roundup August 25, 2020
54 Ophthalmic organizations request FDA reconsider moxifloxacin removal from 503B bulk list
55 ACE Medical Company Receives 510(k) Approval from the FDA
56 Federal government announces vaccines will be FDA approved soon
57 How the FDA should protect its integrity from politics
58 Bill Gates says the FDA lost credibility during pandemic
59 AstraZeneca COVID-19 trial on hold in US as FDA investigates UK participant's serious illness
60 Hey FDA, hands off my fitness tracker | TheHill
61 The FDA's new app for frontline doctors could help discover Covid-19 treatments faster
62 FDA registration renewal deadline looming for US food and feed facilities
63 Trump’s political meddling in the CDC and FDA is downright dangerous
64 Coronavirus (COVID-19) Update: Daily Roundup August 24, 2020
65 FDA: No proof of Covid transmission from food – The Manila Times
66 HHS chief overrode FDA officials to ease testing rules
67 FDA leader says agency could consider authorization for Covid-19 vaccine before Phase 3 trials are complete, Financial Times reports
68 Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
69 Trump has launched an all-out attack on the FDA. Will its integrity survive?
70 Rhenium NanoLiposomes receives Fast Track Designation from FDA for glioblastoma treatment
71 Cadila Healthcare gains 6% on US FDA nod for mineral supplement
72 FDA Proposes Reclassification of Cytomegalovirus Quantitative Tests
73 Quadphasic Synthetic Bone Graft Cleared by FDA
74 Import Screening Pilot Unleashes the Power of Data
75 Riot Lab's first-round PMTA applications accepted by FDA
76 Prima® Wawona Recalls Bagged Peaches Due to Possible Salmonella Risk
77 CorgioMed LLC Issues Voluntary Nationwide Recall of All Lots of Leafree Instant Hand Sanitizer Aloe Vera Labeled as EDIBLE ALCOHOL
78 Popular liver spread included in FDA list of unregistered food products, supplements
79 2 Korean Companies Share 3rd Place in FDA's Evaluation of COVID-19 Diagnostic Kits
80 In FDA's green light for treating COVID-19 with plasma, critics see thin evidence—and politics
81 American College of Radiology among dozens urging FDA to exercise caution in approving COVID-19 vaccine
82 Accelerate Diagnostics Announces New FDA Clearance for Accelerate PhenoTest® Improvements
83 Fitbit’s Sense smartwatch gets FDA clearance for EKG app
84 Sunshine Mills, Inc. Issues Voluntary Recall of Certain Dog Food Products Due to Potentially Elevated Levels of Aflatoxin
85 On COVID, politics infects science at the CDC and the FDA
86 FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework
87 Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early
88 Coronavirus (COVID-19) Update: Daily Roundup August 21, 2020
89 Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels
90 Roche Granted FDA Emergency Use Authorization for Cobas SARS-CoV-2 & Influenza A/B Test
91 Investigational Myeloma Treatment KP1237 Wins FDA Orphan Drug Status
92 FDA Publishes First Batch of SARS-CoV-2 MDx Limit of Detection Comparison Results
93 Second Trump appointee out at FDA amid credibility concerns
94 Equilibrium Inc. (NASDAQ:EQ) Receives Positive Feedback From the FDA On Itolizimab Treating Hospitalized COVID-19 Patients
95 In a 'Lethal' Pandemic, FDA Has to Weigh Vaccine Risks With How Many Lives Could Be Saved, Commissioner Says
96 FDA weighs whether to resume AstraZeneca vaccine trials after patient's serious side effect
97 Roche gets FDA nod for faster combo coronavirus-flu test
98 CCXI To Face FDA In April, CRDF Soars On Colorectal Cancer Trial Data, VCNX In Deal With MRK
99 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
100 Trump Administration Says Some Coronavirus Tests Can Bypass F.D.A. Scrutiny