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FDA-RELATED NEWS
 
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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 Biotech Leaders Support Access to Mifepristone
07/08/2025
 
 
TXT FDA Drops REMS Need for ERA Meds
07/08/2025
 
 
TXT CGMP Violations at Exela Pharma Sciences
07/08/2025
 
 
TXT Support for Biosimilar Legislation
07/08/2025
 
 
TXT FDA Prodded to Improve Surrogate Endpoint Transparency
07/08/2025
 
 
TXT FDA Urged to Expand Real-World Data Use
07/08/2025
 
 
TXT Multiple Insightra Medical Violations Cited
07/08/2025
 
 
TXT Expanded Parkinson’s Use OK’d for Insightec Device
07/08/2025
 
 
TXT FDA Oxylanthanum Carbonate Complete Response Letter
07/07/2025
 
 
TXT FDA Accelerated Approval for Dizal Zegfrovy
07/07/2025
 
 
TXT Staska Multiple Outsourcing Facility Violations
07/07/2025
 
 
TXT Abiomed Pump Controller Needs Update: FDA
07/07/2025
 
 
TXT Delayed Hereditary Angioedema Drug Wins Approval
07/07/2025
 
 
TXT FDA Inspectors Say Conditions Still Hard
07/07/2025
 
 
TXT Priority Review for Merck’s Winrevair
07/07/2025
 
 
TXT Vaccine Regulation Now ‘a Political Process’: Gottlieb
07/07/2025
 
 
TXT Sandoz Recalls 1 Cefazolin Lot
07/07/2025
 
 
TXT FDA Clears Philips’ SmartSpeed Precise Software
07/07/2025
 
 
TXT Myelodysplastic Syndrome Drug Development Guide
07/07/2025
 
 
TXT Positive Phase 3 Results for Moderna Flu Vaccine
07/07/2025
 
 
TXT Bioresearch Monitoring Violations by Dr. Peter Michael
07/07/2025
 
 
TXT Regeneron’s Lynozyfic Approved for Some Myelomas
07/07/2025
 
 
TXT Healwell Homeo Private Selling Adulterated Drugs: FDA
07/07/2025
 
 
TXT Contec and Epsimed Cybersecurity Patch
07/07/2025
 
 
TXT FDA: Website Selling Misbranded, Unapproved Drugs
07/07/2025
 
 
TXT Baxter: Remove Spectrum Infusion Pumps
07/07/2025
 
 
TXT FDA Expands ER-Stimulant Labeling for Weight Loss
07/07/2025
 
 
TXT Guidance on Aluminum Content in Parenteral Drugs
07/07/2025
 
 
TXT FDA Elsa Rollout a ‘Nuanced Dance’: Consultant
07/07/2025
 
 
TXT Sirtex Medical Wins Device OK for Liver Cancer
07/07/2025
 
 
TXT Vacate RFK Jr. Covid Vaccine Recommendations: Lawsuit
07/07/2025
 
 
TXT FDA WEBVIEW CLOSED JULY 4TH WEEK
06/28/2025
 
 
TXT Report Highlights Study Demographic Representation
06/27/2025
 
 
TXT REMS Requirements Ended for CAR T Cell Therapies
06/27/2025
 
 
TXT Appeals Court Backs FDA’s Sameness Interpretation
06/27/2025
 
 
TXT Livmarli, Bylvay Get Liver Injury/Bleeding Updates
06/27/2025
 
 
TXT Atmo Bio’s Gut Capsule Cleared by FDA
06/27/2025
 
 
TXT Antibacterial Therapies Development Q&A Guidance
06/26/2025
 
 
TXT Altimmune Mixed Results for Pemvidutide in MASH
06/26/2025
 
 
TXT UDI Requirements for Combo Products Guide
06/26/2025
 
 
TXT Marks: Why ‘Dramatic Departure’ from Vaccine Policy?
06/26/2025
 
 
TXT Remote Regulatory Assessment Q&A Guidance
06/26/2025
 
 
TXT Device Cybersecurity Quality System Consideration Guide
06/26/2025
 
 
TXT FDA RMAT Designation for Detalimogene
06/26/2025
 
 
TXT Viatris Plans NDA for MR-141 in Presbyopia
06/26/2025
 
 
TXT Sterling Drug Supply Chain Violations
06/25/2025
 
 
TXT Guide on Developing Drugs for Lyme Disease
06/25/2025
 
 
TXT Lilly’s Amyvid Gets Updated Label
06/25/2025
 
 
TXT FDA Approves New Warnings on Covid mRNA Vaccines
06/25/2025
 
 
TXT Stop FDA’s ‘Sudden’ Biosecurity Overreach: Newsletter
06/25/2025
 
 
TXT Reverse FDA Restructuring: Former GOP Representative
06/25/2025
 
 
TXT InspireMD PMA Approved for Carotid Stent
06/25/2025
 
 
TXT Cook Medical Recalls Beacon Angiographic Catheter
06/25/2025
 
 
TXT FDA Olympus Scope Import Alerts
06/24/2025
 
 
TXT Davis Returning to CDER as Deputy Director
06/24/2025
 
 
TXT Makary’s FDA Voucher Program Questioned
06/24/2025
 
 
TXT House Committee Advances FDA Budget Bill
06/24/2025
 
 
TXT Safety Communication on 2 Elevidys-related Deaths
06/24/2025
 
 
TXT CGMP Issues in Pushclean Records Review
06/24/2025
 
 
TXT QS, MDR Violations at S. Korea’s Aju Pharm
06/24/2025
 
 
TXT FDA Skips Panel Review for Capricor Cell Therapy
06/24/2025
 
 
TXT Guideline on Drug Stability Testing Released
06/23/2025
 
 
TXT Inspections Help Prevent Drug Shortages: Study
06/23/2025
 
 
TXT CDER Acting Head Corrigan-Curay Leaving in July
06/23/2025
 
 
TXT Bimagrumab Enhances Weight Loss: Study
06/23/2025
 
 
TXT Medline Issues Correction for Procedure Kits
06/23/2025
 
 
TXT FDA Clears DeepEcho AI Fetal Ultrasound
06/20/2025
 
 
TXT Is FDA Going After RUO Diagnostics?
06/20/2025
 
 
TXT FDA Halts Some Cell Clinical Trials
06/20/2025
 
 
TXT Top 2 FDA Cell/Gene Therapies Officials Pushed Out
06/20/2025
 
 
TXT Securing Technology, Equipment Report
06/20/2025
 
 
TXT Open Bipartisan Probe of RFK Vaccine Plans: Pallone
06/18/2025
 
 
TXT CBER’s Prasad Named Chief Medical/Scientific Officer
06/18/2025
 
 
TXT DTC Ads Kennedy’s Next Target?
06/18/2025
 
 
TXT FDA Approves Gilead’s Yeztugo for HIV Prevention
06/18/2025
 
 
TXT Court OKs FDA Ozempic Drug Shortage Action
06/18/2025
 
 
TXT Gottlieb Believes CBER Will Probe Sarepta Approval
06/18/2025
 
 
TXT FDA Webview Closed on Juneteenth (6/19)
06/18/2025
 
 
TXT Multiple Violations at Reset Technology Corp.
06/17/2025
 
 
TXT Elevidys Shipping Nixed After 2nd Liver‑Failure Death
06/17/2025
 
 
TXT Commissioner’s National Priority Voucher Program
06/17/2025
 
 
TXT Aldeyra Files NDA Resubmission for Dry Eye Drug
06/17/2025
 
 
TXT Zhejiang Huahai Pharmaceutical CGMP Issues
06/17/2025
 
 
TXT OIG Hit FDA Accelerated Approvals
06/17/2025
 
 
TXT FDA Allows Companies to Skip Import Bans: Report
06/17/2025
 
 
TXT Roche Advancing Parkinson’s Drug Into Phase 3
06/16/2025
 
 
TXT Milestone Pharma Files NDA Resubmission for Cardamyst
06/16/2025
 
 
TXT Zyno Medical Recalls Infusion Pumps
06/16/2025
 
 
TXT Qalitex Warns of Growing FDA-Amazon Enforcement Overlap
06/16/2025
 
 
TXT AbbVie's Venetoclax Fails to Improve Survival in Trial
06/16/2025
 
 
TXT Keytruda OK’d for Head-Neck Cancer Pre/Post-Surgery
06/13/2025
 
 
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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;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving