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FDA-RELATED NEWS
 
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TXT GDUFA Post-Warning Letter Meeting Guidance
06/18/2025
 
 
TXT Can Surprise Foreign Drug Inspections Boost Safety?
06/10/2025
 
 
TXT FDA Policy Head on Major Trump Changes at FDA
05/19/2025
 
 
TXT Vanda Tradipitant Scheduling Order Out
05/01/2025
 
 
TXT Little Trust in New Health Leaders: Poll
04/30/2025
 
 
TXT Hill Staffer Graham Appointed to FDA Policy Office
04/16/2025
 
 
TXT Celltrion’s Humira Biosimilar Now Interchangeable: FDA
04/16/2025
 
 
TXT Marks’ Firing Challenges RFK Jr.’s Fitness for Office
03/31/2025
 
 
TXT DOGE-Targeted FDA Lab to Remain Open
03/05/2025
 
 
TXT Alternative Facility Assessment Tools Guidance
09/12/2025
 
 
TXT CBER Says AstraZeneca FluMist Ad Misled Viewers
09/12/2025
 
 
TXT Respironics Recalls DreamStation Ventilators
09/12/2025
 
 
TXT Makary JAMA Piece Explains DTC Ad Crackdown
09/12/2025
 
 
TXT CBER to Host Gene Therapy Manufacturing Town Hall
09/12/2025
 
 
TXT FDA Pushes Plan to Scale Back Advisory Committees
09/12/2025
 
 
TXT Intercept Withdraws Ocaliva Amid Liver Safety Concerns
09/11/2025
 
 
TXT Ways FDA Can Modernize Drug Development
09/11/2025
 
 
TXT FibroGen Paying $1.25 Million to SEC
09/11/2025
 
 
TXT State of Clinical Trials CTTI Meeting Summary
09/11/2025
 
 
TXT FDA to Scrutinize AI-Powered Mental Health Devices
09/11/2025
 
 
TXT Capsida Pauses Gene Therapy Trial After Death
09/11/2025
 
 
TXT Prasad Reassumes Chief Medical/Scientific Officer Role
09/11/2025
 
 
TXT Expanded Approval for AZ’s Koselugo
09/10/2025
 
 
TXT Non-Opioid Analgesic Development Guidance
09/10/2025
 
 
TXT Apollo TMS Cleared for Depressed Adolescents
09/10/2025
 
 
TXT FDA Approves J&J’s New Bladder Cancer Therapy
09/10/2025
 
 
TXT Greenwich Gets Fast Track for Breast Cancer Therapy
09/10/2025
 
 
TXT FDA Orders Crackdown on Misleading Prescription Drug Ads
09/10/2025
 
 
TXT FDA Digital Health Leader Leaves for Mayo Clinic
09/10/2025
 
 
TXT Lexicon Submits New Data on Stalled Diabetes Drug
09/09/2025
 
 
TXT Capricor Posts Bytreldo CRL Response
09/09/2025
 
 
TXT NRx Petitions FDA to Ban Preservative in Ketamine
09/09/2025
 
 
TXT 7th Circuit Backs Dismissal of AbbVie False Claims Suit
09/09/2025
 
 
TXT Microbot Single-Use Robotic Endovascular System Cleared
09/09/2025
 
 
TXT MAHA Reports Aims to Improve Kids’ Health
09/09/2025
 
 
TXT CGMP API Deviations at Hikal Limited
09/09/2025
 
 
TXT Issues in 3 Trials Conducted by Detroit Doctor
09/09/2025
 
 
TXT Former CBER Therapeutics Deputy Anatol Joins Lilly
09/09/2025
 
 
TXT FDA Posts 2 Biosimilar Development Guides
09/08/2025
 
 
TXT Firm Pays $40 Million Over Adulterated Gowns
09/08/2025
 
 
TXT Gottlieb Warns HHS Could Undermine Pediatric Vaccines
09/08/2025
 
 
TXT FDA Guidance on Good Clinical Practice Principles
09/08/2025
 
 
TXT Lilly’s Jaypirca Shows Major Benefit in Leukemia Trial
09/08/2025
 
 
TXT Complete Response on Saol Therapeutics NDA
09/08/2025
 
 
TXT Green List to Block Illegal GLP-1 Imports: FDA
09/05/2025
 
 
TXT CERo Gets Fast Track for Leukemia Therapy
09/05/2025
 
 
TXT FDA Expert Panels Skirt Transparency Standards: Opinion
09/05/2025
 
 
TXT FDA Probing Children’s Deaths from Covid Vaccine: Makary
09/05/2025
 
 
TXT No Committee for Aquestive’s Anaphylm
09/04/2025
 
 
TXT Pyrukynd sNDA Extended Due to REMS Review
09/04/2025
 
 
TXT FDA Says Lilly’s Olomorasib is Breakthrough Therapy
09/04/2025
 
 
TXT 14 GenoGenix Inspection Observations
09/04/2025
 
 
TXT FDA Pledges ‘Prompt’ CRL Release
09/04/2025
 
 
TXT Medtronic Recalls DLP Left Heart Vent Catheters
09/04/2025
 
 
TXT FDA Posts Alopecia Complex Case Study
09/04/2025
 
 
TXT CGMP Violations at Amneal Gujarat, India
09/03/2025
 
 
TXT FDA, CDC Staff Pen Open Letter to Remove RFK Jr.
09/03/2025
 
 
TXT Prasad Has Covid YouTube Videos Pulled
09/03/2025
 
 
TXT FDA Rare Disease Evidence Principles
09/03/2025
 
 
TXT CBER Raising Bar on Future Covid Vaccines
09/03/2025
 
 
TXT FDA Accepts NDA for Smoking Cessation Drug
09/03/2025
 
 
TXT AI Can Cut Drug Development Costs, Time: Experts
09/03/2025
 
 
TXT Merck PCSK9 Inhibitor Meets Trial Goals
09/02/2025
 
 
TXT 4 Observations in AnazaoHealth Inspection
09/02/2025
 
 
TXT FDA’s Political Turn Risks Its Core Mission: Expert
09/02/2025
 
 
TXT Wisconsin Pharmacal CGMP Violations
09/02/2025
 
 
TXT FDA Waives Efficacy Studies for Stelara Biosimilar
09/02/2025
 
 
TXT Medtronic Gets FDA Green Light for Diabetes Devices
09/02/2025
 
 
TXT FDA Vaccines Panel Member Offit Removed
09/02/2025
 
 
TXT CGMP Issues at Compounder’s International
09/02/2025
 
 
TXT FDA Publishes OTC Drug Monograph Forecast
09/02/2025
 
 
TXT Hamilton Recalls Defective Coaxial Breathing Sets
08/29/2025
 
 
TXT Alzheimer’s Therapy Gets At-Home Injection Approval
08/29/2025
 
 
TXT J&J Kills Nipocalimab Plus Tumor Necrosis Factor in RA
08/29/2025
 
 
TXT Novocure Scraps TTFields Study for Real-World Data
08/29/2025
 
 
TXT Medtronic Wins Expanded Use for Evolut Aortic Valve
08/29/2025
 
 
TXT Platinum Biologics Selling Unapproved New Drugs: FDA
08/28/2025
 
 
TXT FDA Rejects Outlook’s Wet AMD Drug Again
08/28/2025
 
 
TXT AdventaPharma Wants Generic Ozempic Conditions
08/28/2025
 
 
TXT Sen. Cassidy Seeks Postponement of Vaccine Panel
08/28/2025
 
 
TXT FDA Recommends More Leqembi MRIs
08/28/2025
 
 
TXT Integra Recalls Surgical Applicators Over Sterility Issues
08/28/2025
 
 
TXT Amylyx Nixes AMX0035 Development After Failed Study
08/27/2025
 
 
TXT FDA Alert on Abiomed Impella Controllers
08/27/2025
 
 
TXT Innate Healthcare Illegally Marketing Stem Cells: FDA
08/27/2025
 
 
TXT Violations in Uscom Spirometer Inspection
08/27/2025
 
 
TXT Limited Covid Vaccines OK’d for Upcoming Season
08/27/2025
 
 
TXT Hikma Injectables FDA-483 Out
08/27/2025
 
 
TXT Researchers Affirm Mifepristone Safety to FDA
08/27/2025
 
 
TXT FDA Looking at MASH Surrogate
08/27/2025
 
 
TXT Lilly Plans NDA for Obesity Pill; Positive Data Released
08/26/2025
 
 
TXT QS Violations at LeMaitre Vascular
08/26/2025
 
 
TXT Allarity’s Stenoparib on FDA Fast Track
08/26/2025
 
 
TXT Axogen Nerve Graft Review Extended by 3 Months
08/26/2025
 
 
TXT 11 QS, MDR Violations at Miach Orthopaedics
08/26/2025
 
 
TXT BIO September Congressional Priorities
08/26/2025
 
 
TXT Multiple GLP Violations at China’s Jiangsu Kerbio
08/26/2025
 
 
TXT FDA Breakthrough Status for Lupis Blood Purifier
08/26/2025
 
 
TXT Chikungunya Vaccine Suspended Due to Safety Concerns
08/25/2025
 
 
TXT FDA Study: CBD Linked to Elevated Liver Enzymes
08/25/2025
 
 
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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;
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