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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 Guidance Details Post-Approval Responsibilities for Generics
06/05/2026
 
 
TXT Stakeholders Press FDA to Pause Voucher Program Amid Transparency Concerns
06/05/2026
 
 
TXT House Passes $7.1 Billion FDA Spending Bill
06/05/2026
 
 
TXT FDA Rejects Xspray Pharma's Nilopki Application
06/05/2026
 
 
TXT Diamantas Tries to Win Back Rare Disease Advocates
06/04/2026
 
 
TXT Faulty Drug Supply Chain Hurts Seniors: Hearing
06/04/2026
 
 
TXT Radiopharmaceutical Companies Want FDA Consistency
06/04/2026
 
 
TXT Supreme Court Sides With Generics in ‘Skinny Label’ Dispute
06/04/2026
 
 
TXT Ways to Improve Biomarker Qualification
06/04/2026
 
 
TXT Bipartisan Bill to Curb Investment in China’s Biotech Sector
06/04/2026
 
 
TXT Pazdur Recommends Restructuring FDA
06/04/2026
 
 
TXT FDA Cites QOL Medical for Misleading Promotion of Sucraid
06/03/2026
 
 
TXT HealthPartners Neuroscience Center BIMO Issues
06/03/2026
 
 
TXT 3-Year New Clinical Investigation Exclusivity Guidance Explained
06/03/2026
 
 
TXT Senate Committee Postpones FDA Funding Bill Consideration
06/03/2026
 
 
TXT FDA Accepts 1st Drug-Induced Liver Injury Tool
06/03/2026
 
 
TXT Cingulate Gets FDA Complete Response Letter on ADHD Drug
06/02/2026
 
 
TXT Repeat Medline CGMP Violations Cited
06/02/2026
 
 
TXT CGMP Violations at Laboratorios Jaloma
06/02/2026
 
 
TXT Manufacturer Economic Info Communications Q&A Guidance
06/02/2026
 
 
TXT Guide on Using Prior Knowledge for Genome Editing Gene Therapies
06/02/2026
 
 
TXT FDA Challenged to Keep Up With ALS Therapies
06/02/2026
 
 
TXT Drop Rabbit Pyrogen Test References: Petition
06/02/2026
 
 
TXT FDA Orders Takeda to Add Boxed Warning to Adzynma
06/02/2026
 
 
TXT FDA Names Veteran Investigator as Head of Inspections/Investigations
06/01/2026
 
 
TXT Be Prepared for New One-Day FDA Inspections: Law Firms
06/01/2026
 
 
TXT Former FDA and HHS Heads Opine on Next Commissioner
06/01/2026
 
 
TXT Report Urges FDA Overhaul for Faster Reviews
06/01/2026
 
 
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 Guide on Reducing Animal Studies for Cancer Products
05/29/2026
 
 
TXT Replimune to Refile Controversial Melanoma BLA
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
 
 
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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;
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