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FDA-RELATED NEWS
 
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TXT Senators Demand HHS Reverse Autism-Related Web Site Changes
03/17/2026
 
 
TXT FDA Enforcement Year in Review
01/27/2026
 
 
TXT Vanda Hetlioz sNDA Not Approvable, FDA Says
01/08/2026
 
 
TXT FDA Warns Apotex Canadian Manufacturing Site
11/05/2025
 
 
TXT FDA Takes Actions to Curb Autism
09/22/2025
 
 
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 All India Institute Clinical Trial Issues
05/20/2026
 
 
TXT Naseem Jaffrani BIMO Violation
05/20/2026
 
 
TXT Will the Next Commissioner Learn from Makary’s Mistakes?
05/20/2026
 
 
TXT FDA Has to Build CRISPR Edit Review Protocol
05/20/2026
 
 
TXT Guidance on Drug Food Effects Studies
05/20/2026
 
 
TXT Bipartisan Bill to Lower Rx Drug Costs
05/20/2026
 
 
TXT FDA Approves Guardant Health’s Next-Generation Guardant360 Liquid CDx
05/20/2026
 
 
TXT CGMP Deviations at Hangzhou Yiqi Biotechnology
05/19/2026
 
 
TXT TEMPO Digital Health Pilot FAQs
05/19/2026
 
 
TXT Harbin Jixianglong Biotech API Deviations
05/19/2026
 
 
TXT Staff Up for Breakthrough Device Recall Oversight: Post
05/19/2026
 
 
TXT Bayer Gets Priority Review for Stroke Drug
05/19/2026
 
 
TXT FDA Covid-19 Pediatric Review Raises New Scrutiny
05/19/2026
 
 
TXT Merck’s Sac-TMT Gets Win in Endometrial Cancer
05/18/2026
 
 
TXT FDA Guide Reshaping Off-Label Communications: Legal Analysis
05/18/2026
 
 
TXT DTC Crackdown Unfazed at Post-Makary FDA: Expert
05/18/2026
 
 
TXT Health Affairs Commentary Says Makary Left FDA ‘Weaker’
05/18/2026
 
 
TXT More FDA Turmoil: Drug, Biologics Leaders Removed
05/18/2026
 
 
TXT AstraZeneca Gets OK for New Hypertension Drug
05/18/2026
 
 
TXT High Court Backs Abortion Pill Access for Now
05/15/2026
 
 
TXT FDA Acting Drugs Head to Leave Agency Soon: Report
05/15/2026
 
 
TXT Democratic Health Leaders Question FDA Study Suppression
05/15/2026
 
 
TXT Critics Pile on Makary’s Ouster with Melanoma Drug Denial
05/15/2026
 
 
TXT Add Warning to OTC Acetaminophen Product Labels: Petition
05/14/2026
 
 
TXT Sun Recalls 1 Batch of Doxorubicin HCl
05/14/2026
 
 
TXT FDA May be OK Under Loper Bright: Article
05/14/2026
 
 
TXT CDER Impurity Acceptance Criteria MAPP
05/14/2026
 
 
TXT FDA in Turmoil as Critics Across Washington Pile On
05/14/2026
 
 
TXT Petition Urges Actions Against Weight Loss Device
05/14/2026
 
 
TXT AEMS May Mean Increased Stakeholder Scrutiny: Column
05/13/2026
 
 
TXT FDA Publishes 2 Analgesic Draft Guidances
05/13/2026
 
 
TXT Brukinsa TV Ad ‘False or Misleading’: OPDP
05/13/2026
 
 
TXT Despite Makary Leaving, Industry Could Feel Pressure: Analysis
05/13/2026
 
 
TXT Guidance Signals Broader Public Health Scrutiny for New Opioids
05/13/2026
 
 
TXT Inspection Pilot May be Permanent as FDA Expands AI-Driven Oversight
05/13/2026
 
 
TXT Israeli Firm Selling Adulterated Unapproved Drugs Online: FDA
05/12/2026
 
 
TXT FDA Commissioner Makary Resigns After Administration Pressure
05/12/2026
 
 
TXT Clarify Draft on FDA-483 Responses: Comments
05/12/2026
 
 
TXT CDER Wants Info for Kidney Safety Biomarker Pilot
05/12/2026
 
 
TXT Ipsen Pulls Tazverik Due to Secondary Blood Cancer Risk
05/12/2026
 
 
TXT Ashirwad Hospital Bioresearch Monitoring Issues
05/12/2026
 
 
TXT FDA Delays Review Action on Alzheimer’s Drug
05/11/2026
 
 
TXT Trump Denies Makary is on the Outs
05/11/2026
 
 
TXT FDA Input Sought on Drug Repurposing
05/11/2026
 
 
TXT Postapproval Pregnancy Safety Studies Guidance Available
05/08/2026
 
 
TXT White House Reportedly Moves to Oust Commissioner Makary
05/08/2026
 
 
TXT Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy
05/08/2026
 
 
TXT New CDER Biologics Compliance Program Explained
05/07/2026
 
 
TXT Report says Makary May Face Ouster Amid White House Tensions
05/07/2026
 
 
TXT CBER Acting Head Highlights Regulatory Flexibility, AI and Rare Disease Priorities
05/07/2026
 
 
TXT Advertising Experts Critique FDA’s Increasing Enforcement
05/07/2026
 
 
TXT Sanofi Seeks Removal of Tzield From FDA Priority Review Program
05/07/2026
 
 
TXT Brookings Economist Backs FDA Biosimilar Draft Guide
05/07/2026
 
 
TXT House Committee Would Limit Foreign Trial Data
05/07/2026
 
 
TXT 10 Observations in Somerset Therapeutics FDA-483
05/07/2026
 
 
TXT Expedite FDA Review of Breakthrough Mental Health Therapies: House Letter
05/06/2026
 
 
TXT One-Day Inspection Pilot Underway at FDA
05/06/2026
 
 
TXT Makary Touts Hiring Push, Clinical Trial Reforms at FDLI
05/06/2026
 
 
TXT FDA Releases Bio-Thera Solutions FDA-483
05/06/2026
 
 
TXT Commissioner’s National Priority Voucher for Bizengri
05/06/2026
 
 
TXT Guidance on CMC Flexibility for Human CGTs
05/06/2026
 
 
TXT FDA Hits Respilon Production for 5 CGMP Violations
05/05/2026
 
 
TXT Recent Accelerated Approval Path Changes Explained
05/05/2026
 
 
TXT FDA, TransCelerate Collaborate on Streamlined Safety Data Collection
05/05/2026
 
 
TXT 3 CGMP Issues At Active Cosmetics Manufacturing
05/05/2026
 
 
TXT Unetixs Vascular Selling Illegal Devices: FDA
05/05/2026
 
 
TXT Makary Outlines Sweeping Reforms to Speed Drug Development
05/04/2026
 
 
TXT High Court Pauses Limits on Mifepristone
05/04/2026
 
 
TXT Alnylam Pharma’s Web Promo is Misleading: FDA
05/04/2026
 
 
TXT Allergan’s Ireland Plant Hit With 483 After Inspection
05/01/2026
 
 
TXT PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance
05/01/2026
 
 
TXT Expanded Access Program for Promising Pancreatic Cancer Drug
05/01/2026
 
 
TXT Eugia Pharma Specialties FDA-483 Out
04/30/2026
 
 
TXT Keep GLP-1s Off Bulks List: FDA
04/30/2026
 
 
TXT Nubeqa TV Ad, Video Misleading: FDA
04/30/2026
 
 
TXT House Committee Advances FDA Funding Bill Amid Policy Disputes
04/30/2026
 
 
TXT FDA Panel Rejects Astrazeneca’s Camizestrant In Closely Watched Vote
04/30/2026
 
 
TXT Enrollment Halted in Newron’s Schizophrenia Study After Patient Death
04/30/2026
 
 
TXT Prospective AI Versioning Standard Needed: Post
04/29/2026
 
 
TXT Purdue Sentencing Sets $5.3 Billion in Criminal Penalties
04/29/2026
 
 
TXT Reviewers Brief ODAC on Camizestrant Concerns
04/29/2026
 
 
TXT Celgene Cell Therapy Facility Hit with Form 483
04/29/2026
 
 
TXT 8 Observations on Fujifilm Diosynth FDA-483
04/29/2026
 
 
TXT CGMP Violations at Lexia LLC
04/29/2026
 
 
TXT Multiple Violations in Foshan Miwei Cosmetics Inspection
04/28/2026
 
 
TXT CGMP Issues at Intas Dehradun Unit
04/28/2026
 
 
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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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