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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 Atmo Bio’s Gut Capsule Cleared by FDA
06/27/2025
 
 
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 FDA WEBVIEW CLOSED JULY 4TH WEEK
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 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 FDA Olympus Scope Import Alerts
06/24/2025
 
 
TXT Davis Returning to CDER as Deputy Director
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 CDER Acting Head Corrigan-Curay Leaving in July
06/23/2025
 
 
TXT Bimagrumab Enhances Weight Loss: Study
06/23/2025
 
 
TXT Guideline on Drug Stability Testing Released
06/23/2025
 
 
TXT Inspections Help Prevent Drug Shortages: 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 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 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 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 Multiple Violations at Reset Technology Corp.
06/17/2025
 
 
TXT Elevidys Shipping Nixed After 2nd Liver‑Failure Death
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
 
 
TXT Senators Introduce Bill to Ban DTC Drug Advertising
06/13/2025
 
 
TXT Oncologic Panel to Review Multiple Myeloma BLA
06/13/2025
 
 
TXT Nipro Class 1 Recall of Hemodialysis Chemical
06/13/2025
 
 
TXT FDA Delays Hereditary Angioedema NDA Decision
06/13/2025
 
 
TXT Medtronic Newport Ventilator Recall Class 1
06/12/2025
 
 
TXT Questions Raised on New ACIP Members
06/12/2025
 
 
TXT Capricor Gets Form-483 After BLA Facility Inspection
06/12/2025
 
 
TXT Researchers Challenge FDA Lamictal Safety Warning
06/12/2025
 
 
TXT More FDA Operational Changes Coming: Makary
06/12/2025
 
 
TXT CDC, NIH Staff Protest Trump Administration Chaos
06/11/2025
 
 
TXT Amish Origins Marketing Unapproved Drugs: FDA
06/11/2025
 
 
TXT FY 2024 Real-World Evidence Statistics Out
06/11/2025
 
 
TXT Bayesian Demo Project Explained
06/11/2025
 
 
TXT Government Drug Price Listening Sessions
06/11/2025
 
 
TXT AbbVie Gains Expanded Label on Hep C Drug
06/11/2025
 
 
TXT FDA to Tweak Industry/Reviewer Communications: Makary
06/11/2025
 
 
TXT FDA Grants, Denies Fenofribrate Petition
06/10/2025
 
 
TXT FDA Puts Hold on Gilead HIV Trials
06/10/2025
 
 
TXT OPDP Finds ‘False, Misleading’ Addyi Post
06/10/2025
 
 
TXT No IND for American Behavioral Study: FDA
06/10/2025
 
 
TXT More Comprehensive AI Regulation Needed: Report
06/10/2025
 
 
TXT Makary/Prasad Priorities for ‘A New FDA’
06/10/2025
 
 
TXT Former FDA Regulatory Counsel Lands at Alston & Bird
06/10/2025
 
 
TXT FDA Backs Jaguar on Cancer Diarrhea Drug Development
06/09/2025
 
 
TXT Pheast Gets Fast Track for Ovarian Cancer Drug
06/09/2025
 
 
TXT RFK Jr. Fires 17 CDC Vaccine Committee Members
06/09/2025
 
 
TXT Merck’s RSV Therapy Approved by FDA
06/09/2025
 
 
TXT FDA Rejects Axsome’s Fibromyalgia Drug Application
06/09/2025
 
 
TXT Novavax Vaccine OK'd After Political Interference: JAMA
06/09/2025
 
 
TXT Baxter Recalls Novum IQ Syringe Pump
06/06/2025
 
 
TXT House Subcommittee Advances FDA Budget Bill
06/06/2025
 
 
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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