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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 Guide on Reducing Animal Studies for Cancer Products
05/29/2026
 
 
TXT Replimune to Refile Controversial Melanoma BLA
05/29/2026
 
 
TXT Drug User Fee Agreement Now Faces Political Debate
05/29/2026
 
 
TXT FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report
05/29/2026
 
 
TXT Medical Device Human Factors Info Submission Guidance
05/28/2026
 
 
TXT 2 Bioequivalence Guidances Published
05/28/2026
 
 
TXT Change FDA Sepsis Screening Strategy: Dingell and McCormick
05/28/2026
 
 
TXT Beren’s Infantile Niemann-Pick disease Drug Review Extended
05/28/2026
 
 
TXT Pitts Named to BrainStorm Cell Therapeutics Board
05/28/2026
 
 
TXT Panel Recommends Dominant Covid Variant for Upcoming Vaccines
05/28/2026
 
 
TXT ‘Objectionable Conditions’ in Dr. Adnan Dahdul's Clinical Trial
05/27/2026
 
 
TXT Lilly Loading Up Vaccines Plate for Former CBER Head Marks
05/27/2026
 
 
TXT Low PCCP Use Could be ‘Missed Opportunity’: Study
05/27/2026
 
 
TXT FDA, Federal Prosecutors Take Tougher Stance on Safety Reporting: Analysis
05/27/2026
 
 
TXT CGMP Violations in GC America Inspection
05/27/2026
 
 
TXT AstraZeneca Breast Cancer NDA Review Extended by FDA
05/27/2026
 
 
TXT Corcept Plans Resubmission of Cushing’s NDA
05/27/2026
 
 
TXT FDA-483 Response Can Influence Future Agency Action: Post
05/27/2026
 
 
TXT Alchymars ICM SM Inspection Issues
05/26/2026
 
 
TXT CGMP Issues at Japan’s Sato Pharmaceutical Co.
05/26/2026
 
 
TXT U.S. Urges High Court Rejection of Compounding Case
05/26/2026
 
 
TXT Outlook Wins FDA Appeal After 3 Complete Responses
05/26/2026
 
 
TXT Intas Pharma Facility in India Hit With Form-483
05/26/2026
 
 
TXT Don’t Expect a New FDA Commissioner Soon: Grossman Column
05/26/2026
 
 
TXT Senator Concerned About Cybersecurity and Chinese Devices
05/26/2026
 
 
TXT ‘Seismic’ Loper Bright Impact Not Yet Seen: Attorneys
05/26/2026
 
 
TXT Clarity Sought on FDA New Approach Methodologies Guide
05/21/2026
 
 
TXT Bolton Thoracic Stent Recall is Class 1: FDA
05/21/2026
 
 
TXT Clinical Electronic Structured Protocol Template
05/21/2026
 
 
TXT Comments on Increasing Access to Non-Prescription Drugs
05/21/2026
 
 
TXT FDA to Convene Panel on Moderna’s mRNA Flu Vaccine
05/21/2026
 
 
TXT RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role
05/21/2026
 
 
TXT Lilly Says Retatrutide Delivered Up to 30% Weight Loss
05/21/2026
 
 
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
 
 
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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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  • The newest product approvals;
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