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FDA-RELATED NEWS
 
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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 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 FDA Proposes Accelerated Approval Pathway for Stealth NDA
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 Susvimo Approved for Diabetic Retinopathy
05/23/2025
 
 
TXT FDA Backs Covid JN.1-Lineage for Next Boosters
05/23/2025
 
 
TXT Judge Blocks Mass Federal Layoffs Pending Appeal
05/23/2025
 
 
TXT BD Recalls Esophagogastric Balloon Tamponade Tubes
05/23/2025
 
 
TXT FDA Approves Liquidia’s Pulmonary Hypertension Drug
05/23/2025
 
 
TXT Accelerated Approval Works: Friends of Cancer Research
05/22/2025
 
 
TXT Tariffs Could Hurt Drug Supply: HuffPost
05/22/2025
 
 
TXT Centerline Bio Recalls Catheter Guidewire
05/22/2025
 
 
TXT MAHA Assessment Details ‘Children’s Health Crisis’
05/22/2025
 
 
TXT Makary Takes Heat for Budget, Mass Firings at Hearing
05/22/2025
 
 
TXT GAO Faults FDA Organ-on-a-Chip Regulation
05/22/2025
 
 
TXT Biocompatibility Testing Labs Falsified Data: FDA
05/22/2025
 
 
TXT ‘Serious’ Research Issues at United Health Products: FDA
05/22/2025
 
 
TXT Moderna Withdraws Pending BLA for Flu/Covid Vaccine
05/21/2025
 
 
TXT QS Violations in NeuroSync Inspection
05/21/2025
 
 
TXT Ethicon Endo-Surgery Recalls Surgical Stapler
05/21/2025
 
 
TXT Microspecialties Quality System Issues
05/21/2025
 
 
TXT Expand mRNA Covid Vaccine Warnings: FDA
05/21/2025
 
 
TXT Bipartisan Bill to Codify Trump Drug Price Order
05/21/2025
 
 
TXT 48 New, Revised PSGs Out
05/20/2025
 
 
TXT Miller Named Acting Inspections Chief
05/20/2025
 
 
TXT FDA Warns Sarfez About Soaanz Promotional Materials
05/20/2025
 
 
TXT Covid Vaccine Policy on Boosters and New Trials
05/20/2025
 
 
TXT SSRI/SNRI Labeling Changes Sought
05/20/2025
 
 
TXT FDA Approves Bayer’s Jivi Antihemophilic Factor
05/20/2025
 
 
TXT Panel Wants More U.S. Patient Data on Glofitamab
05/20/2025
 
 
TXT FDA Chief Counsel Post on Hold for Now
05/19/2025
 
 
TXT Formycon Wins Stelara Interchangeability for Biosimilar
05/19/2025
 
 
TXT Novavax Covid Vaccine Approved After Trial Agreement
05/19/2025
 
 
TXT Severe Itching Linked to Allergy Drugs
05/19/2025
 
 
TXT Stryker Nerve Ablator Cleared for Back Pain
05/19/2025
 
 
TXT Scynexis Clinical Hold Lifted on Antifungal
05/16/2025
 
 
TXT Fujirebio Diagnostics Gets Alzheimer’s Test Cleared
05/16/2025
 
 
TXT FDA Raises Issues on 4 Cancer Drugs at Panel
05/16/2025
 
 
TXT PharmaTher Ketamine NDA Review Extended by FDA
05/16/2025
 
 
TXT Makary to Testify at 5/22 Budget Hearing
05/16/2025
 
 
TXT Amneal’s Brekiya Approved for Migraines
05/15/2025
 
 
TXT FDA Accepts BioCryst Orladeyo NDA
05/15/2025
 
 
TXT Positive Data on Keytruda in Ovarian Cancer: Merck
05/15/2025
 
 
TXT Troriluzole PDUFA Action Date Extended
05/15/2025
 
 
TXT FDA Initiatives Help Early-Phase Cancer Trials: Post
05/15/2025
 
 
TXT Roche Companion Diagnostic for AbbVie’s Emrelis OK’d
05/15/2025
 
 
TXT Agency Has ‘Evolved’ in the Last 10 Years: Verdun
05/15/2025
 
 
TXT Makary Says Vaccine Framework Coming Soon
05/15/2025
 
 
TXT CGMP Violations at China’s Shantou S.E.Z. Baojie
05/14/2025
 
 
TXT FDA Doubts May Move Trials Overseas: Report
05/14/2025
 
 
TXT FDA OKs First Oral Therapy for Rare Adrenal Tumors
05/14/2025
 
 
TXT GAO Pushes Its FDA Recommendations to Kennedy
05/14/2025
 
 
TXT Malaysia’s BioAsia Worldwide CGMP Issues
05/14/2025
 
 
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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;
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