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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 FDA Promotes Centralized Statistical Trial Monitoring
12/13/2024
 
 
TXT FDA Sees New Ocaliva Liver Injuries
12/12/2024
 
 
TXT FDA Hasn’t Inspected Factory with Recalls: ProPublica
12/12/2024
 
 
TXT DTC Ad Enforcement to Increase Under Trump: Panel
12/12/2024
 
 
TXT FDA Regulatory Pathway Needed for Dementia Vaccine Trials: Opinion
06/19/2026
 
 
TXT Committee Backs Moderna Flu Vaccine
06/18/2026
 
 
TXT FDA Wants Testosterone Therapy Labels Updated
06/18/2026
 
 
TXT Review Memo Dismisses Hoeg’s Block on Tzield Approval
06/18/2026
 
 
TXT Expand Some Islet Cell Transplantation Access: Senators
06/18/2026
 
 
TXT Data from First 100 QMSR Inspections Analyzed
06/18/2026
 
 
TXT Senator Seeks FDA Records on Covid Vaccine Safety Review
06/18/2026
 
 
TXT Evaluate Generic Bicalutamide Manufacturers: Petition
06/17/2026
 
 
TXT Agency Seeks Updated Generic Accutane Labels
06/17/2026
 
 
TXT FDA Backs Accelerated Pathway for UniQure Huntington's Therapy
06/17/2026
 
 
TXT FDA Accepts Outlook Therapeutics' Resubmitted BLA for Lytenava
06/17/2026
 
 
TXT Leadership Changes Affect FDA Priorities: Mintz Post
06/17/2026
 
 
TXT Panel to Weigh ‘Favorable’ Data on Moderna's mRNA Flu Vaccine
06/16/2026
 
 
TXT Zoll Medical QSR, MDR Violations
06/16/2026
 
 
TXT CGMP Violations Found in Sante Manufacturing Records
06/16/2026
 
 
TXT FDA Fails at Providing Risk Management Advice: Post
06/16/2026
 
 
TXT Restrict Some Lung Cancer Drugs: Petition
06/16/2026
 
 
TXT FDA Warns Pharmathen Over Sterility, Data Integrity Concerns
06/16/2026
 
 
TXT Jaypirca Combination Cuts Progression Risk by 45% in CLL Trial: Lilly
06/15/2026
 
 
TXT Plausible Mechanism Faces Challenges: Commentary
06/15/2026
 
 
TXT FDA Warns Telehealth Firms on Compounded GLP-1 Marketing
06/15/2026
 
 
TXT FDA Authorizes Colorado Prescription Drug Importation Program
06/15/2026
 
 
TXT FDA, MHRA Launch Liaison Program for Regulatory Cooperation
06/15/2026
 
 
TXT 17 Senate Democrats Hit HHS on FDA, Other Changes
06/11/2026
 
 
TXT Zasocitinib Beats Sotyktu in Head-to-Head Study: Takeda
06/11/2026
 
 
TXT CGMP Violations Seen in Port Jervis Records Review
06/11/2026
 
 
TXT Risk Management an “Ever-Evolving Responsibility”: Thomas
06/11/2026
 
 
TXT Doctor, Staff Charged with Falsifying Trial Data
06/11/2026
 
 
TXT Kidney Risk in OTC Weight Loss Drug Alli
06/10/2026
 
 
TXT Fewer But Longer Drug Shortages: USP Report
06/10/2026
 
 
TXT Require In Vivo BE Test for Tafinlar ANDA: Petition
06/10/2026
 
 
TXT ‘Plausibility Mechanism’ Guidance Needs Clarifications: Article
06/10/2026
 
 
TXT Changes in HCEI Draft Guidance Noted
06/10/2026
 
 
TXT FDA Cites Formulated Solutions Over Manufacturing, Quality
06/10/2026
 
 
TXT Gilead/Merck Stop Trodelvy/Keytruda Study
06/09/2026
 
 
TXT CGMP Violations Found in Zydus Record Review
06/09/2026
 
 
TXT CGMP Issues Cited at Hubei Gedian Humanwell
06/09/2026
 
 
TXT FDA Reinspection of Troubled Novo Nordisk Facility
06/09/2026
 
 
TXT Senators Introduce Bill for Homeopathic Product Pathway
06/09/2026
 
 
TXT Lilly's Oral GLP-1 Outperforms Oral Semaglutide in Diabetes Trial
06/09/2026
 
 
TXT AMA Delegates Call for Tighter FDA Oversight of Unapproved Peptides
06/09/2026
 
 
TXT Clinical Hold on Quantum IND
06/09/2026
 
 
TXT Induced Infringement Decision Analyzed
06/09/2026
 
 
TXT FDA AI Inspections Prompts Industry Readiness Strategy Rethink
06/08/2026
 
 
TXT Agency Defends Generic Drug Oversight
06/08/2026
 
 
TXT FDA Seeks Industry Data for Kidney Biomarker Initiative
06/08/2026
 
 
TXT Alert on GE HealthCare Infant Resuscitation Systems
06/08/2026
 
 
TXT PhRMA Urges FDA to Clarify Digital Health Technology Standards
06/08/2026
 
 
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 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 Diamantas Tries to Win Back Rare Disease Advocates
06/04/2026
 
 
TXT Faulty Drug Supply Chain Hurts Seniors: Hearing
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 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 Cingulate Gets FDA Complete Response Letter on ADHD Drug
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
 
 
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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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  • 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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