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FDA-RELATED NEWS
 
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TXT Keytruda Approved for FIGO Cervical Cancer
01/12/2024
 
 
TXT ICH Viral Safety Evaluation Guidance
01/11/2024
 
 
TXT No Clarity Yet on Ozempic Suicide Risk: FDA
01/11/2024
 
 
TXT Stakeholders Take Shots at FDA SIUU Communication Guide
01/11/2024
 
 
TXT Zeta Surgical Cranial Navigation Device Cleared
01/11/2024
 
 
TXT FDA Needs More Supplement Authority: GAO
01/11/2024
 
 
TXT Florida Drug Import Plan ‘Non-Starter’: Canada
01/11/2024
 
 
TXT CGMP Violations at Woorilife & Health
01/10/2024
 
 
TXT MDR Violations at Neitz Instruments
01/10/2024
 
 
TXT ‘Objectionable Conditions’ in Children’s Hospital Trials
01/10/2024
 
 
TXT Mixed State Court Decision in Tenofovir Case
01/10/2024
 
 
TXT Revised GDUFA Request for Reconsideration Guide
01/10/2024
 
 
TXT CTTI Sees Barriers to Trial Reporting
01/10/2024
 
 
TXT Alcon’s ‘Positive’ Dry Eye Phase 3 Trials
01/10/2024
 
 
TXT Sellas Life Sciences Gets Fast Track
01/10/2024
 
 
TXT CRL for Astellas Zolbetuximab BLA
01/09/2024
 
 
TXT CAR T-Cell Benefits Outweigh Risks: Marks
01/09/2024
 
 
TXT Jungman to be Califf Chief of Staff
01/09/2024
 
 
TXT Potential Chemical Exposure in GE Compressors
01/09/2024
 
 
TXT QS Violations at Czech Device Firm
01/09/2024
 
 
TXT Significant CGMP Violations in Prime Lab LLC
01/09/2024
 
 
TXT FDA OKs Medtronic’s Brain Stimulator
01/08/2024
 
 
TXT First-Cycle Drug Approvals Improve: Report
01/08/2024
 
 
TXT FDA Endorses Vaporized Hydrogen Peroxide
01/08/2024
 
 
TXT Cabaletta Bio Gains Fast Track on CABA-201
01/08/2024
 
 
TXT Endotronic Files PMA for Home Heart Monitor
01/05/2024
 
 
TXT FDA Approves Florida Drug Importation
01/05/2024
 
 
TXT Novartis Radioligand Manufacturing Site Approved
01/05/2024
 
 
TXT Vaccine Hesitancy Threatening Public Health: FDA
01/05/2024
 
 
TXT ModernaTX Hit with 483 Over GMPs
01/05/2024
 
 
TXT Rep. Murphy Wants FDA Artificial Intelligence Info
01/04/2024
 
 
TXT Latest Safety Signal Report Includes Ozempic, Others
01/04/2024
 
 
TXT Siemens New MR Whole-Body Scanner Cleared
01/04/2024
 
 
TXT Hold Lifted on Innate Lymphoma Trials
01/04/2024
 
 
TXT Consolidate Alternative Inspection Guidances: PhRMA
01/04/2024
 
 
TXT ICH/EMA Viral Safety Guide Approved
01/04/2024
 
 
TXT ‘Significant Opportunities’ for FDA Cloud Adoption: Report
01/04/2024
 
 
TXT OCE Working to Simplify Cancer Trials
01/04/2024
 
 
TXT Breakthrough Status for Cancer Detector
01/03/2024
 
 
TXT Public Citizen Announces Death of Sidney Wolfe
01/03/2024
 
 
TXT 3 Observations in Dr. Reddy’s Lab Inspection
01/03/2024
 
 
TXT Update on Drager Neonatal Incubators
01/03/2024
 
 
TXT FDA 2023 Novel Drug Approvals Up
01/03/2024
 
 
TXT FDA Guidance Best Practices Plan
01/03/2024
 
 
TXT Commerce Committee Probes FDA Internal Disputes
01/03/2024
 
 
TXT Laurus Synthesis FDA-483
01/03/2024
 
 
TXT Torrent Pharmaceuticals FDA-483
01/03/2024
 
 
TXT No FDA Funding for RADAR: Public Citizen
01/03/2024
 
 
TXT EUA Filed for Covid Prevention in Immunocompromised
01/03/2024
 
 
TXT FDA OKs Arcutis’ Zoryve Topical Foam for Dermatitis
01/02/2024
 
 
TXT Complete Response Letter for Zealand Infant Drug
01/02/2024
 
 
TXT FDA Updates Kite Yescarta Label
01/02/2024
 
 
TXT No Info from Singapore Drug Company
01/02/2024
 
 
TXT FDA Approves Ionis/AstraZeneca’s Wainua
01/02/2024
 
 
TXT Quality System Issues at Argentina’s Terragene
01/02/2024
 
 
TXT Turkish Drug Company Has CGMP Issues: FDA
01/02/2024
 
 
TXT Clinical Investigation Didn’t Follow Plan: FDA
01/02/2024
 
 
TXT Update on FDA Real-World Evidence Activities
01/02/2024
 
 
TXT Real-World Data Registries Guidance
01/02/2024
 
 
TXT ResMed Updates Labeling for Masks with Magnets
01/02/2024
 
 
TXT Rare Disease Drug Development Guidance
01/02/2024
 
 
TXT Drug Development Master Protocol Guidance
01/02/2024
 
 
TXT Updated Labeling for Promethazine HCl
01/02/2024
 
 
TXT Cell/Gene Product Potency Assurance
01/02/2024
 
 
TXT CGMP Violations at Patco Cosmetics
01/02/2024
 
 
TXT Don’t Use Counterfeit Ozempic: FDA
01/02/2024
 
 
TXT Califf Discusses More Clinical Research Options
01/02/2024
 
 
TXT Topical Ophthalmic Quality Guidance
01/02/2024
 
 
TXT CGMP Violations in Omeza Inspection
01/02/2024
 
 
TXT 2nd CRL for Merck’s Gefapixant Chronic Cough Drug
01/02/2024
 
 
TXT Medline Recalls Trach Care and Cleaning Trays
01/02/2024
 
 
TXT Insight Recalls 1 Lot of Americaine Topical Spray
01/02/2024
 
 
TXT Hua Da Trading Selling Unapproved Viagra: FDA
01/02/2024
 
 
TXT Hospira Recalls 1 Bleomycin Lot
01/02/2024
 
 
TXT QS Issues at Fresenius Medical Care
01/02/2024
 
 
TXT East Fork Cultivars Illegal CBD Products
01/02/2024
 
 
TXT Broadcast Ad ‘Major Statement’ Q&A Guide
01/02/2024
 
 
TXT Dextrum Laboratories CGMP Violations
01/02/2024
 
 
TXT FDA OKs Updated Carvykti Boxed Warning
01/02/2024
 
 
TXT Reformulating Drugs Containing Carbomers
01/02/2024
 
 
TXT Hospira Sodium Bicarbonate Recall
01/02/2024
 
 
TXT Botanical Be Selling Unapproved Drugs: FDA
01/02/2024
 
 
TXT FDA Approves AvertD Opioid Use Test
01/02/2024
 
 
TXT 10 Observations in Aurobindo Facility Inspection
01/02/2024
 
 
TXT Covid-19 Monoclonal Antibody EUA Guidance
01/02/2024
 
 
TXT Amazon Distributing Illegal Drugs: FDA
01/02/2024
 
 
TXT 510(k) Third Party Review EUA Guidance
01/02/2024
 
 
TXT FDA Issuing Device Electronic Export Documents
01/02/2024
 
 
TXT CGMP Violations in Inopak Inspection
01/02/2024
 
 
TXT ‘Deep Flaws’ in FDA Device Oversight: KFF Health News
01/02/2024
 
 
TXT Colonial Dames CGMP Violations
01/02/2024
 
 
TXT QS Violations at Sweden’s Sonesta Medical
01/02/2024
 
 
TXT DHT Remote Data Acquisition Guidance
01/02/2024
 
 
TXT CRL for Amgen Lumakras sNDA
01/02/2024
 
 
TXT NEWSROOM CLOSED FOR THE HOLIDAYS
12/18/2023
 
 
TXT FDA OKs Merck Kidney Cancer Drug
12/17/2023
 
 
TXT FDA OKs Glaukos Intraocular Pressure Drug Implant
12/17/2023
 
 
TXT 2 Imbruvica Accelerated Approvals Withdrawn
12/17/2023
 
 
TXT DTC Survey Examines Quantitative Claims
12/17/2023
 
 
TXT FDA Updates Breast Implant Safety Info
12/17/2023
 
 
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The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
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You can rely on FDA Review to provide only what's important - in the most convenient and time-saving