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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 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 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 Platinum Biologics Selling Unapproved New Drugs: FDA
08/28/2025
 
 
TXT Limited Covid Vaccines OK’d for Upcoming Season
08/27/2025
 
 
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 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 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 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 Breakthrough Status for Quest’s Haystack MRD Test
08/25/2025
 
 
TXT Alert on Hyperbaric Oxygen Devices
08/25/2025
 
 
TXT FDA Broadens Use of Amgen’s Repatha
08/25/2025
 
 
TXT Chikungunya Vaccine Suspended Due to Safety Concerns
08/25/2025
 
 
TXT FDA Study: CBD Linked to Elevated Liver Enzymes
08/25/2025
 
 
TXT Vanda Urges Makary to Intercede in Generic Dispute
08/22/2025
 
 
TXT AdvaMed Urges FDA/CMS Alignment on Breakthrough Devices
08/22/2025
 
 
TXT Boston Scientific Recalls Defective Stent System
08/22/2025
 
 
TXT FDA 483 Shows GMP Troubles at Plant Making Eylea
08/22/2025
 
 
TXT FDA Moves to Daily Drug Adverse Event Data
08/22/2025
 
 
TXT Device Dental Bone Graft Study Guidance
08/21/2025
 
 
TXT Oncology Trial Overall Survival Assessment Guide
08/21/2025
 
 
TXT Stealth Gets Expedited Review on NDA Resubmission
08/21/2025
 
 
TXT Gaps Seen in Dementia AI Device Transparency
08/21/2025
 
 
TXT Rinvoq Meets Endpoints in Alopecia Trial
08/21/2025
 
 
TXT 21% of FDA Staff Gone: Analysis
08/21/2025
 
 
TXT 14 States Join Mifepristone Petition to FDA
08/21/2025
 
 
TXT Workshop on Allergic Dermatitis Patch Test Alternatives
08/20/2025
 
 
TXT Nucleus RadioPharma Names Former FDA Head as CEO
08/20/2025
 
 
TXT FDA Rejects enVVeno Medical Venous Valve PMA
08/20/2025
 
 
TXT FDA Lifts Hold on Rocket’s Gene Therapy
08/20/2025
 
 
TXT Impact of FDA China Cell Rule Unclear: Experts
08/20/2025
 
 
TXT Stop Inaccurate Health Info: HHS Staff to RFK, Jr.
08/20/2025
 
 
TXT FDA Updates Breakthrough Device Statistics
08/20/2025
 
 
TXT FDA DrugSorb-ATR Options
08/20/2025
 
 
TXT Act Against Compounded Semaglutide: Petition
08/20/2025
 
 
TXT 2 Eylea HD Submissions Get Review Extensions
08/20/2025
 
 
TXT Multiple Les Encres Violations
08/19/2025
 
 
TXT CGMP Violations Seen in Anhui Hanbon Inspection
08/19/2025
 
 
TXT FDA Pushes Back Review of Hunter Syndrome BLA
08/19/2025
 
 
TXT PTC Therapeutics’ Friedreich’s Ataxia Drug Rejected
08/19/2025
 
 
TXT Clinical Hold on BiomX Cystic Fibrosis Therapy
08/19/2025
 
 
TXT Viking Reports Mixed Data on Obesity Drug
08/19/2025
 
 
TXT AI-DSF Change Control Plan Guidance
08/19/2025
 
 
TXT FDA Denies Ferring Reconsideration Petition
08/19/2025
 
 
TXT Test and Report Leachable Nitrosamines: FDA
08/19/2025
 
 
TXT NeuroOne’s Trigeminal Nerve Ablation Cleared
08/19/2025
 
 
TXT Cancer Radiopharm. Dosage Guide
08/18/2025
 
 
TXT Stealth Refiles NDA for Barth Syndrome Drug
08/18/2025
 
 
TXT Court Orders FDA to Reconsider Vanda sNDA
08/18/2025
 
 
TXT Advisory Panel Conflicts of Interest Low: Study
08/18/2025
 
 
TXT Tandem Recalls Insulin Pumps Due to Alarm Error
08/18/2025
 
 
TXT Wegovoy OK’d for Metabolic Steatohepatitis
08/18/2025
 
 
TXT FDA Delays Clinical Hold Review on Neurizon ALS Drug
08/15/2025
 
 
TXT FDA Alert on Baxter Novum Infusion Pumps
08/15/2025
 
 
TXT Omeros BLA for Narsoplimab Gets Review Extension
08/15/2025
 
 
TXT FDA OKs Papzimeos for Respiratory Papillomatosis
08/15/2025
 
 
TXT Sickle Cell Drug Misses Phase 3 Endpoint: Pfizer
08/15/2025
 
 
TXT BEAM-101 Gets Advanced Therapy Designation
08/14/2025
 
 
TXT Group Pushes MDMA-Assisted Therapy for PTSD
08/14/2025
 
 
TXT Trump Orders Strategic Reserve of APIs
08/14/2025
 
 
TXT Schrödinger Nixes Leukemia Drug After 2 Deaths
08/14/2025
 
 
TXT Restrictions Asked for Ozempic ANDAs
08/14/2025
 
 
TXT CDER Equal Voice MAPP
08/14/2025
 
 
TXT HHS Revives Task Force on Safer Child Vaccines
08/14/2025
 
 
TXT Thoratec Recalls HeartMate Mobile AC Power Cord
08/14/2025
 
 
TXT Texas Sues Lilly Over ‘Illegal Kickbacks’
08/13/2025
 
 
TXT 2 Charged for Misbranded Imported Drugs
08/13/2025
 
 
TXT De Novo OK for ArteraAI Prostate Software
08/13/2025
 
 
TXT HHS Touts Pharmacy on Demand Project
08/13/2025
 
 
TXT FDAer Quits, Flips Off Trump/Vance in Viral Post
08/13/2025
 
 
TXT Agency RIF Packets Cause Privacy Concerns
08/13/2025
 
 
TXT CGMP Issues at Private Label Grooming
08/12/2025
 
 
TXT Multiple Violations in Spectra Therapy Inspection
08/12/2025
 
 
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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;
  • 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