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1 FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
2 FDA Takes Actions to Help Lower US Prescription Drug Prices
3 FDA Requiring Labeling Changes for Benzodiazepines
4 7 former FDA commissioners: The Trump administration is undermining the credibility of the FDA
5 FDA Launches the Digital Health Center of Excellence
6 FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants
7 FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
8 Oxford Immunotec Announces Food and Drug Administration (FDA) Clearance of the T-SPOT®.TB Test for Use in Pediatrics Over the Age of Two
9 FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
10 Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
11 US Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
12 FDA Official Says Vaccine Makers Know What Data the Agency Expects
13 Lack of inspections, heavy metals cited in FDA enforcement updates
14 FDA Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years
15 FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations
16 The FDA needs more transparency to restore the public's trust
17 Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19
18 Live updates: Former FDA commissioners deliver rare rebuke to Trump administration
19 AbbVie Receives Orphan Drug and Fast Track Designations from the US Food and Drug Administration for Elezanumab
20 New FDA Guidance Will Make It Easier To Approve CBD-Based Medicines
21 FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
22 FDA to soon issue tougher emergency vaccine standards: report | TheHill
23 FDA Approvals of Opioids Based on Insufficient Efficacy and Safety Data
24 5 FDA approval decisions to watch in the 4th quarter
25 FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
26 Spirovant Sciences gets potentially lucrative designation from the FDA
27 Reno manufacturer seeks FDA permit to distribute product
28 COVID-19 vaccine timelines hinge on how trials, FDA approvals work
29 FDA issues warning over TikTok 'Benadryl challenge' | TheHill
30 FDA Official Says Vaccine Makers Know Data Agency Expects
31 Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances
32 National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
33 FDA chief stands by vaccine approval criteria despite Trump pressure
34 Ascendis Pharma A/S Announces US Food and Drug Administration (FDA) Accepts Biologics License Application (BLA) for TransCon™ hGH for Pediatric Growth Hormone Deficiency (GHD)
35 Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pediatric Patients with Adrenocortical Insufficiency
36 Coronavirus (COVID-19) Update: Daily Roundup September 21, 2020
37 FDA pauses advanced coronavirus vaccine trial, but not due to safety concerns
38 U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
39 Sunshine Mills, Inc. Issues Voluntary Recall of Certain Dog Food Products Due to Potentially Elevated Levels of Aflatoxin
40 Ex-FDA leaders warn against Trump manipulation of COVID-19 vaccine
41 An FDA safety program is failing to stem the opioid crisis, report finds
42 Antisense Therapeutics’ FDA ruling could be worth ‘hundreds of millions’
43 The Challenges Facing the Trump Administration's Drug Importation Plan
44 FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule
45 Import Screening Pilot Unleashes the Power of Data
46 Xanax Will Now Come With a More Serious Warning Label
47 If the Food and Drug Administration approved a vaccine for COVID-19 before the end of the year, would you get it if it was free?
48 MMJ BioPharma Cultivation Awaiting DEA Marijuana Cultivation License To Supply FDA Clinical Trials in MS and HD
49 FDA willing to fast track coronavirus vaccine before phase three trials end
50 The US Food and Drug Administration warns of the dangers of...
51 FDA Explains Effects Of CBD And Marijuana Compounds Based On Sex And Gender Differences
52 FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects
53 FDA chief: ‘I will fight for science’
54 FDA Approves Nucala for Hypereosinophilic Syndrome | Health News | US News
55 Real Pet Food Company of Phoenix, AZ Voluntarily Recalls One Lot of Billy+Margot Wild Kangaroo and Superfoods Recipe Dog Food in 4 lb Bags Because of a Possible Salmonella Health Risk (USA)
56 Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive SER-109 Phase 3 Study Results
57 Kudos to McSally for protecting dogs from FDA
58 Study Probes 20-Year FDA Practice of Approving Opioids With Little Safety Data
59 FDA updates recommendation on silver dental fillings
60 New Digital Health Center of Excellence from FDA
61 In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.
62 FDA warns of safety problems at Virginia mammography clinic
63 More products added to FDA hand sanitizer recall list
64 Windtree Gains as FDA Gives Nod to Covid-19-Related Study
65 FDA releases free 'Feed your mind' curriculum to teach students about GMOs
66 The FDA's Oversight of Vaccines is Vital to Public Health
67 Coronavirus (COVID-19) Update: Daily Roundup September 24, 2020
68 Food & Beverage Litigation Update l September 2020 #2 | Shook, Hardy & Bacon LLP
69 FDA to require strongest warning label for common anxiety, insomnia medication
70 Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early
71 Carbon22 Receives FDA 510(k) Clearance for FusionFrame™ Ring Lock System
72 US FDA clears Masimo's handheld pulse oximetry device
73 Bucks County biotech gets FDA approval to begin mid-stage testing of experimental Covid-19 therapy
74 Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
75 Coronavirus (COVID-19) Update: Daily Roundup September 3, 2020
76 Here's how Trump could bigfoot the FDA and get a vaccine out ahead of the science
77 U.S. Food and Drug Administration Approves Onureg® (azacitidine tablets), a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
78 HHS chief overrode FDA officials to ease testing rules
79 The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil
80 Wismettac Asian Foods Voluntarily Recalls Dried Fungus Due to Potential Salmonella Contamination
81 NIH 'very concerned' about serious side effect in AstraZeneca coronavirus vaccine trial
82 COVID-19 Update: FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
83 FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
84 Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
85 FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
86 Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for 'Off-Label' Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems
87 Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments
88 FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
89 Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
90 Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
91 FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging
92 Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
93 USDA, FDA Strengthen US Food Supply Chain Protections
94 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
95 Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
96 Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics
97 Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency
98 FDA Approves Oral Treatment for Spinal Muscular Atrophy
99 Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
100 Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk