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FDA-RELATED NEWS
 
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TXT High Court Skeptical on Mifepristone Restrictions
03/26/2024
 
 
TXT Clinical Data Interchange Standards Update
03/26/2024
 
 
TXT Quantitative Medicine Center of Excellence Created
03/25/2024
 
 
TXT J&J’s Opsynvi OK’d for Pulmonary Hypertension
03/25/2024
 
 
TXT Regeneron Complete Response on Lymphoma BLA
03/25/2024
 
 
TXT FDA Again Seeks Ban on Shock Devices
03/25/2024
 
 
TXT GAO Report Hits FDA on Investigator Retention
03/25/2024
 
 
TXT Arrow QuickFlash Radial Artery Catheter Recall
03/22/2024
 
 
TXT Italfarmaco Wins Approval for Duchenne Drug
03/22/2024
 
 
TXT FTC Challenges Teva Orange Book Listings
03/22/2024
 
 
TXT FDA Settles Ivermectin Messaging Lawsuit
03/22/2024
 
 
TXT Clarity in RWE Guidance is Welcome: Attorneys
03/22/2024
 
 
TXT Organon Wants Generic Nexplanon Restrictions
03/21/2024
 
 
TXT 4 Observations in Medi-Fare Inspection
03/21/2024
 
 
TXT FDA Grants, Denies Draize Test Petition
03/21/2024
 
 
TXT AdvaMed on Metallic Coatings Characterization
03/21/2024
 
 
TXT Safety Labeling Changes for Fluorouracil Injection
03/21/2024
 
 
TXT Vyaire Recalls AirLife Resuscitators
03/21/2024
 
 
TXT Hearing Challenges FDA Rule on LDTs
03/21/2024
 
 
TXT Phase 3 Keytruda Miss in Lung Cancer
03/21/2024
 
 
TXT Elixir Gets ‘Breakthrough’ for DynamX BTK
03/21/2024
 
 
TXT Panel to Discuss Non-invasive Ocular Pump
03/20/2024
 
 
TXT Key Patient Long Covid Meeting Themes
03/20/2024
 
 
TXT Check Key Info in Informed Consent
03/20/2024
 
 
TXT Non-Interventional Studies Guidance
03/20/2024
 
 
TXT CBER AI/ML Web Page
03/20/2024
 
 
TXT Fujifilm AI Colonoscopy Polyp Detector Cleared
03/20/2024
 
 
TXT FDA OKs Tryvio as Add-on for Hypertension
03/20/2024
 
 
TXT Disease Awareness Ads Can Confuse: FDA Study
03/19/2024
 
 
TXT Digital Health Research Grants Available
03/19/2024
 
 
TXT FDA to Make Compounding ‘Difficulty’ Lists
03/19/2024
 
 
TXT Bipartisan Bill to Shore Up Emergency APIs
03/19/2024
 
 
TXT Renal PK Study Guidance
03/19/2024
 
 
TXT Iclusig Accelerated Approval for Leukemia
03/19/2024
 
 
TXT FDA Accepts BLA Resubmission for Lymphir
03/19/2024
 
 
TXT Senators Want Defense Drug Supply Security Update
03/19/2024
 
 
TXT Changes Proposed to Manufacturing Tech Draft
03/19/2024
 
 
TXT FDA Warning Letters on Chinese Syringes
03/19/2024
 
 
TXT FDA Cites GMPs in Abeona Inspection
03/18/2024
 
 
TXT Guide on Animal Drug Mfg. Batches
03/18/2024
 
 
TXT Biotronik Breakthrough Status for Freesolve Device
03/18/2024
 
 
TXT GSK Reports Favorable Jemperli Phase 3 Data
03/18/2024
 
 
TXT Eugia Inspection Results in 7-Item FDA 483
03/18/2024
 
 
TXT Bayer’s Aliqopa Withdrawn Over Failed Confirmation
03/18/2024
 
 
TXT Orchard’s Leukodystrophy Gene Therapy OK’d
03/18/2024
 
 
TXT Sleepnet Recalls Sleep Apnea Masks
03/18/2024
 
 
TXT CDER Launches Inspections Web Page
03/15/2024
 
 
TXT More Info on Quality Manufacturing Maturity
03/15/2024
 
 
TXT Generic Drug Controlled Correspondence Guidance
03/15/2024
 
 
TXT FDA Paper on AI Targets 4 Focus Areas
03/15/2024
 
 
TXT Device Q-Submission Feedback Draft Guidance
03/15/2024
 
 
TXT FDA Guidance on Device Thermal Effects
03/14/2024
 
 
TXT Updated Draft Q-Submission Guidance
03/14/2024
 
 
TXT Comments on Advanced Mfg. Tech Guide
03/14/2024
 
 
TXT Medos Recalls Cerebase DA Guide Sheath
03/14/2024
 
 
TXT Notice Corrected on Flowtuss NDA Withdrawal
03/14/2024
 
 
TXT ‘Damning Report’ on Alzheimer Drug Tests: Article
03/14/2024
 
 
TXT Cassidy Wants Test Regulation Ideas
03/14/2024
 
 
TXT FDA Approves Madrigal Fatty Liver Drug
03/14/2024
 
 
TXT Post-Approval Safety Data Reporting Guide
03/13/2024
 
 
TXT Advisors to Weigh Imetelstat Benefits, Risks
03/13/2024
 
 
TXT ODAC Looking at Increased Deaths in 2 Drugs
03/13/2024
 
 
TXT Need to Creatively Regulate Software as Device: Atty.
03/13/2024
 
 
TXT FDA Budgets to Expand ‘Foreign Footprint’
03/13/2024
 
 
TXT Petition Seeks More Ozempic, Mounjaro Trials
03/13/2024
 
 
TXT Breakthrough Status for Anxiety Disorder Drug
03/13/2024
 
 
TXT PhRMA Seeks Waivers on Patient Medication Info
03/13/2024
 
 
TXT Ensartinib NDA Accepted for Lung Cancer
03/13/2024
 
 
TXT Drug Supply Small Dispenser Info Collection
03/13/2024
 
 
TXT Acadia Pharmaceuticals Nixes Schizophrenia Drug
03/12/2024
 
 
TXT Help Industry with ‘Bad Labs’: Post
03/12/2024
 
 
TXT QS, MDR Issues Seen in Exactech Inspection
03/12/2024
 
 
TXT Minor Drug Labeling Change Reporting Guide
03/12/2024
 
 
TXT ‘False or Misleading’ Senvelgo Claims: CVM
03/12/2024
 
 
TXT Cybersecurity Guidance Updates Proposed
03/12/2024
 
 
TXT Digital Drug Marketing Workshop Themes
03/12/2024
 
 
TXT Most MDRs Hit Device Function Issues: Study
03/12/2024
 
 
TXT Adcetris ‘Positive’ Lymphoma Data: Pfizer
03/12/2024
 
 
TXT Draft Guide on Developing Early Stage Alzheimer’s Drugs
03/11/2024
 
 
TXT Windstone Medical Recalls Surgical Kits
03/11/2024
 
 
TXT FDA Rejects Viatris/Mapi Multiple Sclerosis Drug
03/11/2024
 
 
TXT Abbott Recalls HeartMate Touch System
03/11/2024
 
 
TXT Panel Backs Lumisight Breast Surgical Imaging
03/08/2024
 
 
TXT Wegovy OK’d for Reducing Cardiovascular Death
03/08/2024
 
 
TXT FDA Delays Lilly Alzheimer’s Drug for Panel Review
03/08/2024
 
 
TXT Amylyx Mulls Withdrawing ALS Drug
03/08/2024
 
 
TXT Lilly Requests EUA Revocation for Covid Combo
03/08/2024
 
 
TXT KVK Paying $3.5 Million in Guilty Plea
03/07/2024
 
 
TXT Positive Phase 1 Data on New Novo Weight-Loss Drug
03/07/2024
 
 
TXT Accelerated Approval for Brukinsa for Some Lymphomas
03/07/2024
 
 
TXT Alliance for Regenerative Medicine AMT Concerns
03/07/2024
 
 
TXT Opdivo Approved in First-Line Bladder Cancer
03/07/2024
 
 
TXT 6 Reps Want FDA Voucher for Valley Fever
03/07/2024
 
 
TXT ICH Analytical Procedure Development Guidance
03/06/2024
 
 
TXT Use Healthcare AI for Patients First: Califf
03/06/2024
 
 
TXT ICH Analytical Procedure Validation Guidance
03/06/2024
 
 
TXT Pfizer’s Besponsa Expanded Use in Pediatric Leukemia
03/06/2024
 
 
TXT MIDD Pilot Lessons Learned
03/06/2024
 
 
TXT Quanterix Gets Breakthrough Status for Alzheimer’s Test
03/06/2024
 
 
TXT sNDA for Ozempic Planned for Kidney Disease
03/05/2024
 
 
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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:
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  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
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  • Related industry news capsules;
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