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FDA-RELATED NEWS
 
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TXT Lexicon Refiling NDA for Sotagliflozin in Diabetes
03/12/2024
 
 
TXT $500 Million Boost to FDA in President’s Budget Proposal
03/11/2024
 
 
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TXT Bayer’s Aliqopa Withdrawn Over Failed Confirmation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 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 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TXT Device Q-Submission Feedback Draft Guidance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
 
 
TXT FDA Approves Sandoz’ Prolia, Xgeva Biosimilars
03/05/2024
 
 
TXT Budget Compromise Gives FDA $160 Million Boost
03/05/2024
 
 
TXT 1st OTC Continuous Glucose Monitor Cleared
03/05/2024
 
 
TXT Bell Intrnatl. Labs Warned Over CGMP Violations
03/05/2024
 
 
TXT CGMP Violations Found at Colgin
03/05/2024
 
 
TXT QS, MDR Violations at Fresenius Kabi Facility
03/05/2024
 
 
TXT New Dietary Ingredient Notification Guidance
03/05/2024
 
 
TXT Comments on FDA Guidance Best Practices
03/05/2024
 
 
TXT Follow Law’s Intent on Drug Innovation: Scott, Carter
03/05/2024
 
 
TXT Boston Scientific PMA OK’d for Stent
03/04/2024
 
 
TXT ‘Fresh Allograft Heart Valves’ Regulated by FDA
03/04/2024
 
 
TXT Zevra Therapeutics NDA Review Extended
03/04/2024
 
 
TXT Hold Lifted on Iovance Lung Cancer Trial
03/04/2024
 
 
TXT Oregon Medical Cited Over Social Media Claims
03/04/2024
 
 
TXT Endo Hit with $2 Billion Fine Over Opioid Sales
03/01/2024
 
 
TXT FDA Denies Approval/Hearing on Vanda Stalled sNDA
03/01/2024
 
 
TXT Datex-Ohmeda Air Compressor Recall is Class 1
03/01/2024
 
 
TXT Allecra NDA Approval for Antibiotic
03/01/2024
 
 
TXT FDA Guide on Informed Consent Key Info
03/01/2024
 
 
TXT J&J Gets Full Approval for Rybrevant
03/01/2024
 
 
TXT CDRH Cautions on Breast Implant Removal
02/29/2024
 
 
TXT Antibody-Drug Conjugate Guidance
02/29/2024
 
 
TXT Hard for States to Meet Import Rules: Califf
02/29/2024
 
 
TXT Electrical OR Table Problems
02/29/2024
 
 
TXT Ex-PCA Head Sentenced to 6 Months in Jail
02/29/2024
 
 
TXT Wipro GE Healthcare Recalls Incubators
02/29/2024
 
 
TXT Animal Lab Issues at Musk Neuralink Site
02/29/2024
 
 
TXT Proposed Wound Product Rule Draws Fire
02/28/2024
 
 
TXT Fake Weight Loss Drugs Concern Califf
02/28/2024
 
 
TXT Medtronic Recalls Cerebrospinal Fluid Drain
02/28/2024
 
 
TXT U.S. Generally Fastest in New Drug Launches
02/28/2024
 
 
TXT Baxter Debarment Reduced by 3 Years
02/28/2024
 
 
TXT Supreme Court Could Hit FDA Regulation: FDLI
02/28/2024
 
 
TXT Marks Sees ‘Breakout Year’ in Gene Therapy Approvals
02/28/2024
 
 
TXT Questions on Topical Ophthalmic Draft Guide
02/28/2024
 
 
TXT ‘Significant’ CGMP Violations at Amman Pharmaceutical
02/27/2024
 
 
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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:
  • 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;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving