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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 Telix NDA Resubmission for Brain Cancer Imaging Agent
04/10/2026
 
 
TXT FDA rejects Replimune Melanoma Therapy Again
04/10/2026
 
 
TXT Rep. Auchincloss Seeks FDA Whistleblowers
04/10/2026
 
 
TXT Vanda Blasts FDA Plan to Lengthen Drug Review Times
04/09/2026
 
 
TXT Will the Push for DTC Pre-Review Grow?
04/09/2026
 
 
TXT RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms
04/09/2026
 
 
TXT Alymsys Patient Brochure False or Misleading: FDA
04/09/2026
 
 
TXT America First Fee Incentives Discussed in PDUFA Meeting
04/09/2026
 
 
TXT Inspection Cites Thermo Fisher Manufacturing Facility
04/09/2026
 
 
TXT FDA Budget Proposal Signals Push for Tighter Ad Oversight
04/08/2026
 
 
TXT Insmed Halts Brensocatib Program After Mid-Stage Trial Miss
04/08/2026
 
 
TXT See Supply Chain Strategy as Core Regulatory Function: Attorney
04/08/2026
 
 
TXT FDA Not Keeping Pace with Non-Oncology Basket Trials: Column
04/08/2026
 
 
TXT FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study
04/08/2026
 
 
TXT Mass Compounding Threatens FDA Enforcement: Column
04/08/2026
 
 
TXT Medline Industries QS Violations Cited
04/07/2026
 
 
TXT FDA Opens READI-Home Innovation Challenge
04/07/2026
 
 
TXT Groups Urge Congress to Advance Generic Drug Bills
04/07/2026
 
 
TXT FDA Grants Outlook Therapeutics’ Dispute Resolution Request
04/07/2026
 
 
TXT Federal Judge Pauses Challenge to Abortion Pill Rules
04/07/2026
 
 
TXT Doctor Failed to Follow Investigational Plan: FDA
04/07/2026
 
 
TXT Organogenesis Advances ReNu Toward FDA Filing After Key Meeting
04/07/2026
 
 
TXT ImmunityBio Responds to FDA Concerns Over Promotional Materials
04/06/2026
 
 
TXT FDA 483 Guidance Raises Compliance Bar: Cooley
04/06/2026
 
 
TXT FDA Budget Request Seeks 3% Increase
04/06/2026
 
 
TXT FDA Patient Preference Guide Addresses 510(k) Applicability
04/06/2026
 
 
TXT FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments
04/03/2026
 
 
TXT October Deadline for New Adverse Event Reporting Standard
04/03/2026
 
 
TXT HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns
04/03/2026
 
 
TXT CBER File Over Protest SOPP
04/02/2026
 
 
TXT FDA Expanding Real-World Evidence Use in Device Regulation
04/02/2026
 
 
TXT FDA Enforcement Discretion for Some Hemp CBD Products
04/02/2026
 
 
TXT Trump Plans New Tariffs on Pharmaceutical Industry
04/02/2026
 
 
TXT FDA Denies CAD/CADt Device 510(k) Exemption Petition
04/02/2026
 
 
TXT Bipartisan Senators Urge FDA to Pre-Screen Certain Drug Ads
04/02/2026
 
 
TXT Makary Signals Push for Faster Approvals, and Sweeping Reforms
04/02/2026
 
 
TXT New CBER Head Should Restore Rare Disease Clarity: Advocates
04/01/2026
 
 
TXT Multiple Violations at LeeSar Outsourcing Facility
04/01/2026
 
 
TXT Multiple Violations in Physitemp Instruments Inspection
04/01/2026
 
 
TXT Appeals Court Hears GLP-1 Compounding Testimony
04/01/2026
 
 
TXT FDA Seeks Faster IND-To-Approval Timelines, Expanded OTC Access
04/01/2026
 
 
TXT Lilly’s Oral Obesity Drug Foundayo Wins Approval
04/01/2026
 
 
TXT FDA-483 Not a Proxy for Overall Quality: Califf
03/31/2026
 
 
TXT CGMP Deviations in Henan Lvyuan Inspection
03/31/2026
 
 
TXT Modernize DTC Ads with QR Code: WLF
03/31/2026
 
 
TXT NIH-Funded Study to Assess GLP-1 Drugs in Alzheimer’s
03/31/2026
 
 
TXT FDA Says Proposed Drug Import Guidance ‘Unwarranted’
03/31/2026
 
 
TXT FDA Seeking Input on Expanding Digital Health Tech in Trials
03/31/2026
 
 
TXT FDA Pharma Disclosures Raise Transparency-Confidentiality Tensions
03/30/2026
 
 
TXT FDA Records Reveal Lapses in Drug Safety Checks: Analysis
03/30/2026
 
 
TXT FDA Crackdown on CAR-T Promotion in Coordinated Action
03/30/2026
 
 
TXT Merck’s Oral PCSK9 Candidate Cuts LDL Cholesterol in Late-Stage Trial
03/30/2026
 
 
TXT FDA Flags Manufacturing/Labeling Violations at STAQ Pharma Ohio Facility
03/27/2026
 
 
TXT FDA Guide on Patient Preferences in Device Submissions
03/27/2026
 
 
TXT Editorial Criticizes Makary Over Leadership Decisions
03/27/2026
 
 
TXT Podcast Explains New Bayesian Methods Trial Guidance
03/26/2026
 
 
TXT FDA Considering Industry PDUFA 8 Incentive Proposal
03/26/2026
 
 
TXT GDUFA Research Helped Product-Specific Guidances: Report
03/26/2026
 
 
TXT Don’t Consider Conflict of Interest Policies in Isolation: Professor
03/26/2026
 
 
TXT Follow Law on Advisory Committees: Petition
03/26/2026
 
 
TXT Watchdog Blasts FDA Over Rising Costs, Higher Rejections
03/26/2026
 
 
TXT Experts Highlight FDA’s Push for Bespoke Genetic Therapy Pathway
03/26/2026
 
 
TXT Multiple Violations at Longhorn Vaccines and Diagnostics
03/25/2026
 
 
TXT FDA Asks for Rezolute’s Ersodetug Data After Trial Miss
03/25/2026
 
 
TXT FDA Open to Single Phase 3 for Netherton Syndrome Drug
03/25/2026
 
 
TXT 4 Observations on Micro Labs ’483
03/25/2026
 
 
TXT Corcept’s Lifyorli Combo in Platinum-Resistant Ovarian Cancer Approved
03/25/2026
 
 
TXT HELP Republican Senators Urge FDA Mifepristone Action
03/25/2026
 
 
TXT 5 Key Points in New FDA Weight Loss Device Guidance
03/25/2026
 
 
TXT 4 CGMP Issues in the Yangzhou Company Inspection
03/24/2026
 
 
TXT QS Violations at IsoTis OrthoBiologics
03/24/2026
 
 
TXT More Conflict of Interest Transparency Needed: GAO
03/24/2026
 
 
TXT Meaning of Prasad’s Departure Debated
03/24/2026
 
 
TXT ‘Race to the Bottom’ Generic Model Threatens Quality/Supply: Expert
03/24/2026
 
 
TXT ImmunityBio Warning Letter Over Misleading Promotion of Anktiva
03/24/2026
 
 
TXT Adventa Nintedanib Petition Granted, Denied
03/24/2026
 
 
TXT FDA Requires New Seizure Warning for Parkinson’s Drugs
03/23/2026
 
 
TXT Legal Update Highlights FDA’s Guide on 3 Year Exclusivity
03/23/2026
 
 
TXT Influencers’ Drug Promotions Pose Public Health Risks: JAMA
03/23/2026
 
 
TXT ICH Signals New Standards for Advanced Drug Manufacturing
03/23/2026
 
 
TXT Lilly Retatrutide Meets Key Primary, Secondary Endpoints
03/19/2026
 
 
TXT Warning Letter Cites ‘Right-to-Try’ Law
03/19/2026
 
 
TXT Sarepta to Submit Amondys 45 and Vyondys 53 sNDAs
03/19/2026
 
 
TXT Novo Nordisk’s High-Dose Wegovy Approved
03/19/2026
 
 
TXT Rare Disease Advocates Stage ‘Funeral’ at FDA Headquarters
03/19/2026
 
 
TXT Multiple Avertix Medical Violations Cited
03/18/2026
 
 
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