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1 Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
2 COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
3 Coronavirus (COVID-19) Update: February 23, 2021
4 FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy
5 US Drug Regulator Removes Key Requirement for Future COVID Vaccine Approvals
6 Johnson & Johnson's one-shot COVID-19 vaccine effective and safe- FDA staff
7 Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
8 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate
9 FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders
10 FDA Provides the Latest COVID Updates
11 FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older
12 FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
13 Puzzle Medical Devices Inc. Receives US Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump
14 Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into US, Protect US Consumers
15 Chinook Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for CHK-336 for Treatment of Primary Hyperoxaluria
16 FDA grants clearance for Rhythmlink's Sticky Pad Surface Electrodes
17 Heart Valve Collaboratory Announces U.S. Food and Drug Administration Participation in Collaborative Community
18 FDA Names First Acting Director Of Medical Device Cybersecurity
19 Johnson & Johnson's one-shot COVID-19 vaccine effective, safe: FDA staff
20 ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Expanded Use of Cabenuva (cabotegravir, rilpivirine) as an HIV Treatment for Use Every 2-Months
21 Coronavirus (COVID-19) Update: February 5, 2021
22 FDA says J&J 1-dose shot prevents COVID; final decision soon
23 U.S. FDA Accepts for Priority Review Pfizer's... | INN
24 Intrommune Receives IND Clearance From US Food and Drug Administration for INT301
25 Tebentafusp Named FDA Breakthrough Therapy for Advanced Eye Cancer
26 Locate Bio's Chondro3 Granted FDA Breakthrough Device Designation
27 Coronavirus (COVID-19) Update: January 26, 2021
28 Jacobs Institute hires Carlos Pena, formerly of US Food and Drug Administration's Office of Neurological and Physical Medicine Devices
29 Biofrontera submits study report of pharmacokinetics study to FDA
30 Janssen's Single-Dose COVID-19 Vaccine Under FDA Review
31 Dascena Announces FDA Breakthrough Device Designation Granted to Machine Learning Diagnostic Method
32 Kura Oncology Receives FDA Breakthrough Therapy Designation for Tipifarnib in Head and Neck Squamous Cell Carcinoma
33 Newsfeed Now: FDA finds Johnson & Johnson’s COVID-19 vaccine effective and safe; veterinarians say six-legged puppy ‘a miracle’
34 FDA, in Initial Review of NurOwn for ALS, Finds Data Lacking
35 Can AI help to improve seafood safety?
36 2021 Biopharma Update on the Novel Coronavirus: February 23
37 NDAL MFG INC Issues Voluntary Nationwide Recall of ManukaGuard Allercleanse Nasal Spray Due to Contamination with Yeast
38 El Abuelito Recalls Queso Fresco Products Because of Possible Health Risk
39 Johnson & Johnson requests emergency authorization from FDA for Covid vaccine
40 Data confirms single-dose Covid-19 vaccine is safe: Live updates
41 Dow Jones Today, Stocks Sag Ahead Of Powell, Day 2; J&J Jumps On FDA Vaccine Comments
42 Ellodi Pharmaceuticals Announces Fast Track Designation Granted by the FDA to APT-1011 for the Treatment of Eosinophilic Esophagitis (EoE)
43 Import alerts include problems with cheese, shrimp, misbranding, pesticides
44 2020 at FDA: A Year of Unparalleled Contributions to Public Health
45 FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine
46 FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
47 FDA, Mexican Counterparts Enhance Food Safety Partnership
48 FDA Warns Companies Illegally Selling CBD Products | FDA
49 FDA Approves First Treatment for COVID-19
50 FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
51 Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators
52 FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients
53 FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs
54 FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
55 FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order
56 CBP, FDA Seize Counterfeit, Unauthorized E-Cigarettes
57 FDA Approves First Drug to Treat Rare Metabolic Disorder
58 FDA Releases New Outbreak Investigation Table
59 FDA Takes Actions to Help Lower US Prescription Drug Prices
60 FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses
61 FDA Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications
62 FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
63 FDA Requiring Labeling Changes for Benzodiazepines
64 FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
65 FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
66 FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia
67 FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
68 FDA Launches the Digital Health Center of Excellence
69 FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs
70 Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
71 FDA Releases Artificial Intelligence/Machine Learning Action Plan
72 Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System
73 US Food and Drug Administration approves Pfizer Covid-19 vaccine
74 FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations
75 FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer
76 USDA, FDA Strengthen US Food Supply Chain Protections
77 FDA Encourages Manufacturers to Clearly Declare All Uses of Sesame in Ingredient List on Food Labels
78 COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
79 FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
80 FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
81 FDA Warns Companies Illegally Selling Hangover Remedies
82 FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord
83 FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance
84 FDA Approves First Treatment for Ebola Virus
85 Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate
86 FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging
87 Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
88 FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories
89 FDA Warns Website Operators Illegally Selling Opioids to Consumers
90 FDA Approves Oral Treatment for Spinal Muscular Atrophy
91 Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools
92 FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults
93 Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
94 FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
95 Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
96 FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
97 FDA Warns Dietary Supplement Companies Illegally Selling Products Containing Cesium Chloride
98 COVID-19 Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
99 FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
100 Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19