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FDA-RELATED NEWS
 
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TXT FDA Lifts Alert on Neonatal Incubators
01/17/2025
 
 
TXT AstraZeneca’s Calquence Wins Traditional Approval
01/17/2025
 
 
TXT CDRH Authorized 120 Novel Devices in 2024
01/17/2025
 
 
TXT Animal Drug Regs Amended for Recent Approvals
01/17/2025
 
 
TXT Amgen’s Lumakras/Vectibix OK’d in Colon Cancer
01/17/2025
 
 
TXT CDER Commits to 11 Drug Quality Guides in 2025
01/17/2025
 
 
TXT FDA ‘Complete Response’ on Atara’s Ebvallo
01/16/2025
 
 
TXT Anti-Neuropathy Guidance for Cancer Drugs
01/16/2025
 
 
TXT FDA Seeks Comments on Cannabis Use in Animals
01/16/2025
 
 
TXT Commissioners’ Suggestions for Martin Makary
01/16/2025
 
 
TXT Boehringer Schizophrenia Cognition Trial Misses Endpoints
01/16/2025
 
 
TXT Medline Fluid Delivery Sets Recalled
01/16/2025
 
 
TXT FDA Early Alert on Fresenius Pump Software Updates
01/16/2025
 
 
TXT FDA Policy Head Lands at King & Spalding
01/15/2025
 
 
TXT QS Violations at Xoran Technologies
01/15/2025
 
 
TXT 8 Observations in Phillips Precision Inspection
01/15/2025
 
 
TXT AdvaMed Trial Participation Snapshot Comments
01/15/2025
 
 
TXT Former McKinsey Exec Pleads Guilty in Opioid Case
01/15/2025
 
 
TXT Lilly’s Omvoh Wins Expanded Approval
01/15/2025
 
 
TXT J&J Bladder Cancer Drug Under Review
01/15/2025
 
 
TXT Getinge/Maquet Recalls VasoView HemoPro 2 Devices
01/15/2025
 
 
TXT Vanda Can Seek Tradipitant Hearing: FDA Notice
01/15/2025
 
 
TXT 7 QS Issues at 3 Integra Facilities
01/14/2025
 
 
TXT Hologic QS and MDR Violations
01/14/2025
 
 
TXT 12 No-Longer-Marketed NDAs Withdrawn
01/14/2025
 
 
TXT OIG Faults 3 of 24 FDA Accelerated Approvals
01/14/2025
 
 
TXT Nitrosamine CPCA Expedites Drug Approvals: FDA
01/14/2025
 
 
TXT ANDA Oligonucleotide Guides Needed: AAM
01/14/2025
 
 
TXT Subcutaneous Leqembi BLA Accepted for Review
01/14/2025
 
 
TXT Icotec Carbon Fiber Spinal Infection Implant Cleared
01/14/2025
 
 
TXT Spear Bio Gets Breakthrough Status on Alzheimer's Test
01/14/2025
 
 
TXT Califf Final Essay Touts Covid Vaccines
01/13/2025
 
 
TXT Priority Review for Lung Cancer BLA
01/13/2025
 
 
TXT Philips Recalls ECG Mobile Monitoring App
01/13/2025
 
 
TXT Guide on Device PMA/HDE Modular Reviews
01/13/2025
 
 
TXT Rigel Pharma Gets Orphan Status for R289
01/13/2025
 
 
TXT FDA Turmoil Before Trump: CDER Chief Quits
01/10/2025
 
 
TXT 18,000 ‘Appalled’ Physicians Urge Senate Rejection of RFK Jr.
01/10/2025
 
 
TXT FDA Accepts NDA for Menkes Disease Drug
01/10/2025
 
 
TXT Tenpoint Therapeutics’ Positive Data on Vision Drug
01/10/2025
 
 
TXT CapsoVision Capsule Endoscopy Home Use Cleared
01/10/2025
 
 
TXT Vertex Cystic Fibrosis NDA Used Priority Voucher
01/09/2025
 
 
TXT FDA to Review Agios Pyrukynd sNDA
01/09/2025
 
 
TXT FDA Puts Marengo’s Invikafusp on Fast Track
01/09/2025
 
 
TXT Fresenius Recalls Ivenix Infusion Pumps
01/09/2025
 
 
TXT J&J Pauses Varipulse Rollout
01/09/2025
 
 
TXT Breakthrough Status for Heart Failure Device
01/09/2025
 
 
TXT Create Labeling-only NDA: Report
01/09/2025
 
 
TXT 6 Human Cell, Tissue Donor Eligibility Guides
01/08/2025
 
 
TXT Priority Review for Verastem Ovarian Cancer NDA
01/08/2025
 
 
TXT Diversity Action Plan Submissions Up
01/08/2025
 
 
TXT XO Biologix Marketing Unapproved, Adulterated Drug
01/08/2025
 
 
TXT FDA Fast Track for J&J Alzheimer’s Drug
01/08/2025
 
 
TXT 1st Cycle NDA Approvals Fall in 2024: CDER
01/08/2025
 
 
TXT FDA Sees ‘Challenges’ in Condoliase BLA
01/08/2025
 
 
TXT Vanda Criticizes FDA Over Drug Rejection
01/08/2025
 
 
TXT Anne’s Daye Pulls CBD Tampons in U.S.
01/08/2025
 
 
TXT Optical Imaging Drug Development Guidance
01/07/2025
 
 
TXT 5 Repeat CGMP Violations at Indoco Remedies
01/07/2025
 
 
TXT FDA Obesity/Overweight Drug Development Guide
01/07/2025
 
 
TXT ‘Off-Label’ Communications Q&A Guide
01/07/2025
 
 
TXT Rybrevant/Lazcluze Cancer Study Positive: J&J
01/07/2025
 
 
TXT 2 ALS Drugs Miss Endpoints
01/07/2025
 
 
TXT Lifecycle Recommendations for AI-Enabled Devices
01/07/2025
 
 
TXT Sex Differences in Clinical Evaluations of Products
01/07/2025
 
 
TXT RSV Vaccines Get Guillain-Barré Warning
01/07/2025
 
 
TXT Ionis’ Spinraza Approved by FDA for SMA
01/06/2025
 
 
TXT Guide on Device Supply Interruption Notifications
01/06/2025
 
 
TXT Guide on Seeing if Confirmatory Study Underway
01/06/2025
 
 
TXT Inogen Airway Clearance Device Cleared
01/06/2025
 
 
TXT Guide on Clinical Trials Using Tissue Biopsies
01/06/2025
 
 
TXT Draft Guide on Using AI for Drug Development
01/06/2025
 
 
TXT Neumora’s Phase 3 Depression Study Misses Endpoints
01/06/2025
 
 
TXT CDER Approved 50 Novel Products Last Year
01/06/2025
 
 
TXT FDA OKs Array’s Braftovi for Some Cancers
01/06/2025
 
 
TXT FDA OKs Galderma Dermatitis Drug Nemluvio
01/06/2025
 
 
TXT Alcon Recalls Systane Ultra PF Eye Drops
01/06/2025
 
 
TXT FDA Approves Novo Hemophilia Prophylaxis Drug
01/03/2025
 
 
TXT New Sleep Apnea Indication for Lilly’s Zepbound
01/03/2025
 
 
TXT Astellas Recalls Lots of Prograf and Astagraf
01/03/2025
 
 
TXT Bhargava Phytolab CGMP Violations
01/03/2025
 
 
TXT FDA Wants Labeling Changes for Buprenorphine
01/03/2025
 
 
TXT Global Unique Device ID Database Guidance
01/03/2025
 
 
TXT QS, MDR Violations at Rontis Hellas in Greece
01/03/2025
 
 
TXT FDA Approves BMS’ Opdivo Qvantig Injection
01/03/2025
 
 
TXT FDA Approves Checkpoint’s Unloxcyt
01/03/2025
 
 
TXT FDA Approves Xcovery’s Ensacove for Some Lung Cancers
01/03/2025
 
 
TXT FDA Approves Humacyte’s Symvess
01/03/2025
 
 
TXT FDA Alert on Boston Accolade Pacers Early Replacement
01/03/2025
 
 
TXT Axsome Plans Alzheimer’s NDA on Mixed Data
01/03/2025
 
 
TXT Exclude Liraglutide from Compounding: Novo Nordisk
01/03/2025
 
 
TXT Mylan 6-Item Form FDA-483 Posted
01/03/2025
 
 
TXT CGMP Violations in Micro Orgo Chem Inspection
01/03/2025
 
 
TXT Guide on Drug Batch Uniformity and Integrity
01/03/2025
 
 
TXT Chimerix NDA for Glioma Drug
01/03/2025
 
 
TXT Temple Retires; Bumpus Leaves FDA
01/02/2025
 
 
TXT Xbrane Refiles Lucentis Biosimilar BLA
01/02/2025
 
 
TXT Alert on AquaFlexFlow Blood Circuits
01/02/2025
 
 
TXT Senators Introduce Skinny Label Generic Drug Bill
01/02/2025
 
 
TXT Hologic BioZorb Marker Recall Class 1: FDA
01/02/2025
 
 
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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:
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  • 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;
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