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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 Multiple Violations at China’s Xiamen Kang
04/21/2026
 
 
TXT New FDA AEMS Dashboard Needs Context, Transparency: Professors
04/21/2026
 
 
TXT Makary Support Vouchers for Psychedelic Therapies
04/21/2026
 
 
TXT Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava
04/21/2026
 
 
TXT CGMP Violations at Par Health USA/Endo USA
04/21/2026
 
 
TXT FDA Lays Out Next Phase of Plan to Reduce Animal Testing
04/20/2026
 
 
TXT Trump Signs Executive Order to Accelerate Psychedelic Therapies
04/20/2026
 
 
TXT Padcev-Keytruda Combo for Broader Bladder Cancer
04/20/2026
 
 
TXT FDA Sets Higher Approval Bar for Passage Bio Dementia Therapy
04/20/2026
 
 
TXT Philips Wins Clearance for AI-powered Spectral CT System
04/17/2026
 
 
TXT Guidance on Impurity Standards For Fermentation-Based Antibiotics
04/17/2026
 
 
TXT Collins Presses for Faster Generic Competition at Hearing
04/17/2026
 
 
TXT White Paper on Improving Accelerated Approval Path
04/16/2026
 
 
TXT AdvaMed Recommendations for Class 2 Notification Exemption
04/16/2026
 
 
TXT Trump Names Erica Schwartz to Head CDC
04/16/2026
 
 
TXT Lilly to Seek FDA Approval for Foundayo in Diabetes
04/16/2026
 
 
TXT Kennedy Hearing Repeatedly Raised FDA Actions
04/16/2026
 
 
TXT Town Hall Discusses QMSR Basics and Answers Questions
04/15/2026
 
 
TXT Change Labeling for Hormonally Active Contraceptives: Petition
04/15/2026
 
 
TXT FDA Extends Molgramostim BLA Review for 3 Months
04/15/2026
 
 
TXT FDA’s No. 2 Brenner May Move to CDC Senior Role
04/15/2026
 
 
TXT FDA Updates Compliance Program for Biologic Drug Manufacturers
04/15/2026
 
 
TXT 2 CDER Postmarketing MAPPS Out
04/15/2026
 
 
TXT FDA Panel Meeting to Mull Adding Peptides to Compounding List
04/15/2026
 
 
TXT CGMP Violations Found at Medical Products Laboratories
04/14/2026
 
 
TXT Multiple Issues in Purolea Cosmetics Lab Inspection
04/14/2026
 
 
TXT Don’t Underestimate Device Quality System Inspection Changes: Column
04/14/2026
 
 
TXT Guidance on Sequencing Standards for Genome Editing Therapies
04/14/2026
 
 
TXT Exelixis Wants 505(b)(2) Cabometyx Restrictions
04/14/2026
 
 
TXT FDA Form 483 Response Guidance Outlined
04/14/2026
 
 
TXT Quality, Data Integrity Issues Flagged at Indian API Maker Hikal
04/14/2026
 
 
TXT FDA Urges Trial Sponsors to Disclose Missing Clinical Study Results
04/13/2026
 
 
TXT Greater Alignment Needed for External Control Arms: Stakeholders
04/13/2026
 
 
TXT Eye Doctor Emerges as Contender for CBER Head
04/13/2026
 
 
TXT Pfizer’s Adcetris Social Media Ads are Misleading: FDA
04/13/2026
 
 
TXT Cato Institute urges FDA overhaul to keep pace with AI
04/13/2026
 
 
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
 
 
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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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