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FDA-RELATED NEWS
 
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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 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 Lawyer 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 Amneal Recalls Contaminated Tablets
06/06/2025
 
 
TXT Arvinas Files NDA for Breast Cancer Drug
06/06/2025
 
 
TXT Baxter Recalls Novum IQ Syringe Pump
06/06/2025
 
 
TXT House Subcommittee Advances FDA Budget Bill
06/06/2025
 
 
TXT FDA OKs Petition to Correct Phathom Patent Listing
06/06/2025
 
 
TXT FDA: Draeger Recall is Class 1
06/05/2025
 
 
TXT ICH M11 Technical Specification Guidance Out
06/05/2025
 
 
TXT House Posts FDA Budget Mirroring Trump’s Proposal
06/05/2025
 
 
TXT FDA Platform Technology OK for Sarepta Vector
06/05/2025
 
 
TXT New Safety-Related Hernia Mesh Label Recommendations
06/05/2025
 
 
TXT Drug Labeling Improved for Pregnant Women: FDA
06/05/2025
 
 
TXT 4 States Want Mifepristone REMS Ended
06/05/2025
 
 
TXT Makary Pushes for Reductions in Regulatory Barriers
06/05/2025
 
 
TXT QS Issues at DFI Company
06/04/2025
 
 
TXT Pay Attention to FDA AI Reviews: Attorneys
06/04/2025
 
 
TXT Smiths Issues 3 Recalls on Infusion Pumps
06/04/2025
 
 
TXT CGMP Issues at Huangshi Hygienic
06/04/2025
 
 
TXT Draft Guide on OTC Drug Minor Changes
06/04/2025
 
 
TXT Evi Labs CGMP Violations
06/04/2025
 
 
TXT Pandemic Diagnostic Testing Plan Needed: GAO
06/04/2025
 
 
TXT 2 FDA Officials Part of Wrongful Termination Lawsuit
06/04/2025
 
 
TXT Sources Question FDA Internal AI: NBC
06/04/2025
 
 
TXT Makary Pledges Mifepristone Study
06/03/2025
 
 
TXT Makary Struggles to Clarify New Covid Recommendations
06/03/2025
 
 
TXT Rechon Life Sciences Violations
06/03/2025
 
 
TXT CGMP Violations at Zhejiang Easyclean
06/03/2025
 
 
TXT FDA Drops LDT Regulation, Looks to RUOs: Attorneys
06/03/2025
 
 
TXT CBER’s Prasad Outlines Rare Disease Goals
06/03/2025
 
 
TXT Clarity Breast Gets FDA De Novo Authorization
06/03/2025
 
 
TXT Zeta Given Another Hat at FDA — Special Counsel
06/03/2025
 
 
TXT Bipartisan Push Seeks Boost in ALS Research
06/02/2025
 
 
TXT FDA Budget Proposal Details $400 Million in Cuts
06/02/2025
 
 
TXT Moderna Wins OK for Next-Gen Covid Vaccine
06/02/2025
 
 
TXT Appeals Court Halts Federal Layoffs
06/02/2025
 
 
TXT Improved Swoop Portable Brain MRI Cleared
06/02/2025
 
 
TXT Guide on Bioequivalence for Immediate-Release Drugs
05/30/2025
 
 
TXT Aurolife NC Drug Plant Hit With Form-483
05/30/2025
 
 
TXT Group Seeks Warnings on Nuvigil, Provigil
05/30/2025
 
 
TXT Drug Firms Agree to Pay $51 Million in Pay-to-Delay Suit
05/30/2025
 
 
TXT Breakthrough Status for Artificial Heart
05/30/2025
 
 
TXT MAHA Report Questioned on ‘Nonexistent Science’
05/30/2025
 
 
TXT FDA Proposes Accelerated Approval Pathway for Stealth NDA
05/29/2025
 
 
TXT HHS Nixes Moderna Bird Flu Vaccine Funding
05/29/2025
 
 
TXT Attorney Warns: FDA Watching Professional Promotion
05/29/2025
 
 
TXT Patritumab BLA Pulled by Merck/Daiichi
05/29/2025
 
 
TXT Congressmen Hit FDA Covid Vaccine Limit
05/29/2025
 
 
TXT Drug Product Color Additive Replacement Guide
05/29/2025
 
 
TXT Promising Trial Results for Wegovy Add-on: Veru
05/28/2025
 
 
TXT Zhejiang Huahai FDA-483 Released
05/28/2025
 
 
TXT Former McKinsey Partner Sentenced for Purdue Work
05/28/2025
 
 
TXT Multiple Issues at Germany’s DRG Instruments
05/28/2025
 
 
TXT House Democrats Want Answers on HHS Staff Cuts
05/28/2025
 
 
TXT FDA Publishes 2 Q-Submission Guidances
05/28/2025
 
 
TXT 26 FDA Orphan Drug Approvals in 2024
05/28/2025
 
 
TXT RFK Jr. Attacks ‘Corrupt’ Drug Firms and DTC Ads
05/28/2025
 
 
TXT Sen. Durbin Queries FDA on Drug Promo Staff Cuts
05/28/2025
 
 
TXT To Make FDA Great Again, Impeach RFK Jr.
05/27/2025
 
 
TXT Inspection Issue at AACE Pharmaceuticals
05/27/2025
 
 
TXT Quality System Issues in Spain’s Sedecal Inspection
05/27/2025
 
 
TXT Warning Letter to Kabe Follows Recent Safety Alert
05/27/2025
 
 
TXT Congress Should End Government Layoffs: Professor
05/27/2025
 
 
TXT Covid Vaccine Nixed for Children/Pregnant Women
05/27/2025
 
 
TXT Gene Therapy Trial on Hold After Death
05/27/2025
 
 
TXT FDA Clears Olympus Endoscope Series
05/27/2025
 
 
TXT Savara Gets Refusal-to-File Letter for Molbreevi BLA
05/27/2025
 
 
TXT BD Recalls Esophagogastric Balloon Tamponade Tubes
05/23/2025
 
 
TXT FDA Approves Liquidia’s Pulmonary Hypertension Drug
05/23/2025
 
 
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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