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FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
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FDA Takes Actions to Help Lower US Prescription Drug Prices
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FDA Requiring Labeling Changes for Benzodiazepines
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7 former FDA commissioners: The Trump administration is undermining the credibility of the FDA
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FDA Launches the Digital Health Center of Excellence
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FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants
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FDA Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
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Oxford Immunotec Announces Food and Drug Administration (FDA) Clearance of the T-SPOT®.TB Test for Use in Pediatrics Over the Age of Two
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FDA Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
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Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
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US Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
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FDA Official Says Vaccine Makers Know What Data the Agency Expects
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Lack of inspections, heavy metals cited in FDA enforcement updates
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FDA Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years
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FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations
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The FDA needs more transparency to restore the public's trust
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Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19
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Live updates: Former FDA commissioners deliver rare rebuke to Trump administration
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AbbVie Receives Orphan Drug and Fast Track Designations from the US Food and Drug Administration for Elezanumab
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New FDA Guidance Will Make It Easier To Approve CBD-Based Medicines
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FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
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FDA to soon issue tougher emergency vaccine standards: report | TheHill
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FDA Approvals of Opioids Based on Insufficient Efficacy and Safety Data
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5 FDA approval decisions to watch in the 4th quarter
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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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Spirovant Sciences gets potentially lucrative designation from the FDA
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Reno manufacturer seeks FDA permit to distribute product
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COVID-19 vaccine timelines hinge on how trials, FDA approvals work
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FDA issues warning over TikTok 'Benadryl challenge' | TheHill
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FDA Official Says Vaccine Makers Know Data Agency Expects
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Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances
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National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
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FDA chief stands by vaccine approval criteria despite Trump pressure
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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)
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Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pediatric Patients with Adrenocortical Insufficiency
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Coronavirus (COVID-19) Update: Daily Roundup September 21, 2020
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FDA pauses advanced coronavirus vaccine trial, but not due to safety concerns
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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)
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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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Ex-FDA leaders warn against Trump manipulation of COVID-19 vaccine
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An FDA safety program is failing to stem the opioid crisis, report finds
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Antisense Therapeutics’ FDA ruling could be worth ‘hundreds of millions’
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The Challenges Facing the Trump Administration's Drug Importation Plan
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FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule
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Import Screening Pilot Unleashes the Power of Data
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Xanax Will Now Come With a More Serious Warning Label
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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?
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MMJ BioPharma Cultivation Awaiting DEA Marijuana Cultivation License To Supply FDA Clinical Trials in MS and HD
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FDA willing to fast track coronavirus vaccine before phase three trials end
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The US Food and Drug Administration warns of the dangers of...
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FDA Explains Effects Of CBD And Marijuana Compounds Based On Sex And Gender Differences
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FDA Updates Breast Implant Labeling Recommendations to Help Inform Patients About Dangerous Potential Side Effects
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FDA chief: ‘I will fight for science’
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FDA Approves Nucala for Hypereosinophilic Syndrome | Health News | US News
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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)
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Seres Therapeutics Announces U.S. Food and Drug Administration Correspondence Following Positive SER-109 Phase 3 Study Results
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Kudos to McSally for protecting dogs from FDA
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Study Probes 20-Year FDA Practice of Approving Opioids With Little Safety Data
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FDA updates recommendation on silver dental fillings
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New Digital Health Center of Excellence from FDA
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In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.
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FDA warns of safety problems at Virginia mammography clinic
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More products added to FDA hand sanitizer recall list
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Windtree Gains as FDA Gives Nod to Covid-19-Related Study
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FDA releases free 'Feed your mind' curriculum to teach students about GMOs
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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 24, 2020
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Food & Beverage Litigation Update l September 2020 #2 | Shook, Hardy & Bacon LLP
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FDA to require strongest warning label for common anxiety, insomnia medication
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Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early
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Carbon22 Receives FDA 510(k) Clearance for FusionFrame™ Ring Lock System
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US FDA clears Masimo's handheld pulse oximetry device
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Bucks County biotech gets FDA approval to begin mid-stage testing of experimental Covid-19 therapy
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Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
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Coronavirus (COVID-19) Update: Daily Roundup September 3, 2020
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Here's how Trump could bigfoot the FDA and get a vaccine out ahead of the science
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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
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HHS chief overrode FDA officials to ease testing rules
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The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet Due to the Presence of Undeclared Sildenafil
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Wismettac Asian Foods Voluntarily Recalls Dried Fungus Due to Potential Salmonella Contamination
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NIH 'very concerned' about serious side effect in AstraZeneca coronavirus vaccine trial
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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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FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
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Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine
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FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
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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
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Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments
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FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
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Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests
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Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
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FDA Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging
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Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system
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USDA, FDA Strengthen US Food Supply Chain Protections
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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
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Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
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Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics
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Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency
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FDA Approves Oral Treatment for Spinal Muscular Atrophy
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Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
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Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
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