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1 Bravo Packing, Inc. Recalls All Performance Dog and Ground Beef Raw Pet Food Because of Possible Salmonella and Listeria Monocytogenes Health Risk to Humans and Animals
2 FDA clamps down on bogus device 'registration certificates' amid rising use during pandemic
3 FDA Releases Fake Registration Certificates Statement
4 FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy
5 FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
6 Marlboro Maker Lobbies FDA to Say Not All Nicotine Products Are Bad
7 The New Head Of the FDA On COVID-19 Tests And Vaccines
8 Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
9 FDA lays out data modernization action plan
10 Democrats push FDA to regulate toxic metals in baby food after investigation finds high levels
11 FDA's Data Modernization Action Plan: Putting Data to Work
12 Does 'Emergency Use Authorization' mean the vaccines have been approved by the FDA?
13 FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation
14 Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog
15 Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
16 Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
17 FDA releases a new plan to bring its data skills up to speed
18 FDA Authorizes Marketing of Novel Device to Help Protect Athletes' Brains During Head Impacts
19 Hedgehog food recalled over salmonella concerns: FDA
20 Op-Ed: FDA dangerously slow-walks at-home testing
21 FDA's inspection woes to grow if agency doesn't address COVID-19 backlog: GAO
22 ADA, others urge FDA to ban menthol cigarettes, other nontobacco flavored tobacco products
23 ControlRad Announces FDA Clearance for ControlRad Select
24 FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns
25 Angle PLC Announces Update on submission for FDA clearance
26 After Outcry Over Rejected ALS Therapy, FDA Explains Itself
27 FDA slaps AstraZeneca, Fibrogen with last-minute roxadustat AdComm, cuing another delay for anemia drug
28 COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
29 FDA approves 'Q-Collar' to help protect athletes from brain injuries
30 MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
31 Coronavirus (COVID-19) Update: FDA Continues Important Work to Support Medical Product Development to Address New Virus Variants
32 National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
33 Novadip Biosciences receives IND approval from the FDA for regenerative bone product NVD-003
34 FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy
35 Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
36 FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders
37 FibroGen shares sink as FDA meeting decision suggests another delay for top drug
38 Former FDA chief urges rethinking COVID risk metrics
39 Clinical Trials Advance as Tesomet Granted FDA's Orphan Drug Status
40 Novavax seeks FDA emergency approval for COVID-19 vaccine by May
41 FDA Warns Against Taking Veterinary Medicine for COVID-19
42 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate
43 As BrainStorm continues to tout 'clear signal' on ALS drug, the FDA offers a rare public slapdown on the data
44 Coronavirus (COVID-19) Update: February 26, 2021
45 KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD
46 Soliton ramps up commercialization of RESONIC device after FDA clearance
47 Sugar Land biopharmaceutical company gets FDA approval to treat COVID-19 long haulers with adult stem cells
48 Ocular Therapeutix™ Announces FDA Acceptance of Supplemental New Drug Application for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
49 ControlRad® Announces FDA Clearance for ControlRad Select
50 Pfizer's Lorbrena Wins Full FDA Approval As First Line Treatment Of ALK-Positive Lung Cancer
51 KMPH Scores FDA Nod For ADHD Drug, MNOV Quits COVID-19 Vaccine Race, UTHR Gives Up On Trevyent
52 Can your employer require the COVID-19 vaccine? FDA-approved versus emergency use authorization at the center of debate
53 The Daily Biotech Pulse: FDA Nod For Pfizer, Kiniksa Rises On Commercialization Pact With Regeneron, Bio-Techne To Buy Diagnostic Company
54 FDA Documents Achievements and Plans for Future
55 FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use Device
56 FDA Appoints Acting Director Of Medical Device Security, Signaling Increased Commitment To Medical Device Cybersecurity
57 FDA warns COVID trial sponsor for failing to submit IND
58 Sight Sciences Receives FDA Clearance for Expanded Indication for OMNI Surgical System
59 Cook Medical lands FDA breakthrough status in latest round of cardio-themed nods
60 Creative Medical Technology Holdings Provides Update on ImmCelz® FDA Application
61 Eye drops submitted for FDA approval aim to replace need for some eyeglasses
62 FDA calls out Brainstorm's ALS stem cell therapy, says data don't show benefit
63 Xentria Asks FDA to Authorize Clinical Trial of XTMAB-16 for Sarcoidosis
64 Novavax expects FDA clearance for Covid vaccine as early as May, CEO says
65 FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
66 Single-dose vaccine approved by FDA – The George-Anne Media Group
67 Coronavirus (COVID-19) Update: February 23, 2021
68 Ridley Block Operations Voluntarily Recalls Three Batches of Crystalyx® Sheep-lyxTM
69 Luminex Obtains FDA Emergency Use Authorization for Expanded Respiratory Panel With SARS-CoV-2
70 FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
71 FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older
72 Federal judge enters permanent injunction against New York-based dietary supplement manufacturer
73 Tired of reading glasses? Eye drop submitted for FDA approval may help you read without them
74 Clue gets FDA clearance for digital birth control
75 FDA's Generic Drug Program in 2020 Helped Ensure Availability of High-Quality, Affordable Drugs Amid COVID-19
76 FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products
77 10-minute home COVID test approved by FDA
78 Coronavirus (COVID-19) Update: February 5, 2021
79 Nanox in direct contact with FDA reviewers as startup negotiates approval of novel imaging system
80 FDA investigating e-cigarette maker selling fruit-flavor vaporizers despite ban | TheHill
81 Shook Hardy adds former FDA associate chief counsel to regulatory practice
82 Vaccinations Could Go Faster If FDA, CDC Adjusted Risk Calculus
83 Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer
84 FDA accepts Regeneron's Dupixent application for children with asthma
85 FDA clears IND application for cell therapy to treat congenital pseudarthrosis of the tibia
86 FDA Clears Wearable Brain Neuromodulation Device for Acute Migraine
87 FDA approves new one-dose vaccine
88 FDA Grants Priority Review to Injectable Pafolacianine Sodium to Identify Ovarian Cancer During Surgery
89 Rutgers Professor Appointed to FDA's Tobacco Products Scientific Advisory Committee
90 The Quaker Oats Company Issues Voluntary Recall of Quaker Rice Crisps Sweet Barbecue Flavor Due to Undeclared Soy Issue
91 Who Will Be the Next F.D.A. Chief?
92 FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
93 FDA's enforcement discretion for digital health is more ambiguous than ever in 2021
94 Coronavirus (COVID-19) Update: February 12, 2021
95 El Abuelito Recalls Queso Fresco Products Because of Possible Health Risk
96 Shenandoah Growers, Inc Issues a Limited, Voluntary Recall of Specific Imported Organic Basil Because of Potential Health Risk
97 FDA could reject AstraZeneca's COVID-19 vaccine on efficacy and manufacturing shortfalls: analyst
98 Novartis' blockbuster heart med Entresto snags FDA approval in larger patient group
99 Mallinckrodt faces regulatory delay as COVID-19 restrictions continue to upend FDA's inspection schedule
100 As Millions Get Covid Vaccine Shots, F.D.A. Struggles With Safety Monitoring