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FDA-RELATED NEWS
 
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TXT How Soon Will Trump Nominate Next FDA Head?
11/07/2024
 
 
TXT 9 Observations in Staska Pharmaceuticals FDA-483
11/06/2024
 
 
TXT Clozapine REMS Curbs Treatment: Comments
11/06/2024
 
 
TXT FDA OKs LumiThera Dry AMD Treatment
11/06/2024
 
 
TXT Caris’ Companion Diagnostic for Cancer Approved
11/06/2024
 
 
TXT ACLA Views on PCCP Draft Guidance
11/06/2024
 
 
TXT RFK Jr. Says Some FDA Departments Have to Go
11/06/2024
 
 
TXT Breakthrough Designation for SeaStar Dialysis Device
11/06/2024
 
 
TXT Extended Review for Organon’s Vtama sNDA
11/05/2024
 
 
TXT ‘Objectionable Conditions’ at Hospital IRB
11/05/2024
 
 
TXT FDA Can’t Regulate AI on its Own: Califf
11/05/2024
 
 
TXT FDA OKs Envoy Medical Cochlear Implant Study
11/05/2024
 
 
TXT CGMP Issues at China’s Shandong Boyuan
11/05/2024
 
 
TXT Analytical Food Laboratories CGMP Violations
11/05/2024
 
 
TXT Merus Zeno BLA Gets 3 Month Review Extension
11/05/2024
 
 
TXT Support, Suggestions for FDA Rare Disease Hub
11/05/2024
 
 
TXT Lawyer Says Not Enough FDA Digital Health Standards
11/05/2024
 
 
TXT Pilot Evaluating Quicker Reviews for Some Drugs
11/04/2024
 
 
TXT Clinical Holds Lifted on 3 CARsgen Cell Products
11/04/2024
 
 
TXT Phase 3 Study on Disc Medicine’s Bitopertin
11/04/2024
 
 
TXT Quanta Dialysis Home Dialysis Device Cleared
11/04/2024
 
 
TXT Mark Cuban’s Generic Operation Hit with 483
11/04/2024
 
 
TXT Ionis NDA for Hereditary Angioedema Attacks
11/04/2024
 
 
TXT Journey Rosacea Drug Approved by FDA
11/04/2024
 
 
TXT Percussionaire Recalls Breathing Circuits
11/01/2024
 
 
TXT FDA Taps Comstock Rick for Rare Disease Hub
11/01/2024
 
 
TXT Aarti Drugs India Plant Hit with FDA-483
11/01/2024
 
 
TXT Sen. Rubio Seeks to Ban Certain APIs from China
11/01/2024
 
 
TXT Panel Rejects Lexicon Pharma Diabetes Drug
11/01/2024
 
 
TXT FDA Reconsiders CAR-T Product Warning: Marks
11/01/2024
 
 
TXT FDA: Compounders Should Use ‘Suitable’ Ingredients
10/31/2024
 
 
TXT FDA Extends Some Baxter Parenteral Drug Product Use Dates
10/31/2024
 
 
TXT Warning on Skin-Cap Spray Products
10/31/2024
 
 
TXT Exactech 3D-Printed Knee Implant Cleared
10/31/2024
 
 
TXT Use Risk-Based AI/ML Regulation: AstraZeneca
10/31/2024
 
 
TXT Datex-Ohmeda Recalls Giraffe OmniBeds
10/31/2024
 
 
TXT UCB’s Bepranemab Misses Primary Endpoint
10/31/2024
 
 
TXT Verastem Oncology NDA for Rare Ovarian Cancer
10/31/2024
 
 
TXT Court Backs FDA Lumryz Approval
10/31/2024
 
 
TXT Guides on Bioequivalence Study Designs
10/31/2024
 
 
TXT Organon/Shanghai Henlius Seek Biosimilar Approval
10/30/2024
 
 
TXT ICH Bioquivalence Guidance Out
10/30/2024
 
 
TXT Spanberger Wants More ADHD Drug Info
10/30/2024
 
 
TXT Boehringer Ingelheim Inspection Report Posted
10/30/2024
 
 
TXT FDA Removes Imaging Ban on FreeStyle Libre
10/30/2024
 
 
TXT Advisors Asked About Lexicon’s Sotagliflozin
10/30/2024
 
 
TXT FDA, VA to Test Health AI Tools
10/30/2024
 
 
TXT PTC Therapeutics NDA Resubmission for Duchenne Drug
10/30/2024
 
 
TXT CGMP Violations at Turkey’s MedOffice Saglik
10/29/2024
 
 
TXT 8 Observations in Novo Nordisk FDA-483
10/29/2024
 
 
TXT FDA Sets Acceptable NITMA Level for Ritonavir Products
10/29/2024
 
 
TXT Abeona Refiles BLA for Gene Therapy
10/29/2024
 
 
TXT GE Healthcare EVair Recall Actions No Longer Apply: FDA
10/29/2024
 
 
TXT Protega Abuse-Deterrent Oxycodone Approved
10/29/2024
 
 
TXT Canadian Drug Imports Won’t Help U.S.: Study
10/29/2024
 
 
TXT Trump as President May Tap RFK for FDA Head
10/29/2024
 
 
TXT FDA Won’t Require Qsymia CV Outcome Trial
10/29/2024
 
 
TXT House GOPs Demand Clinical Data on Puberty Blockers
10/28/2024
 
 
TXT Info Collection on Antimicrobial Animal Drug Sales
10/28/2024
 
 
TXT Broader FDA Interpretations Needed for Review Vouchers: Hill
10/28/2024
 
 
TXT FDA Sued Over Drug Compounding Restrictions
10/28/2024
 
 
TXT PharmaTher Complete Response Letter on Ketamine
10/28/2024
 
 
TXT De Novo Authorization for Dexter Surgical Robot
10/28/2024
 
 
TXT Medtronic’s Affera Mapping/Abalation Device Approved
10/25/2024
 
 
TXT Kinova Recalls Wheelchair Robotic Arm
10/25/2024
 
 
TXT Iterum Therapeutics’ Antibiotic OK’d for UTIs
10/25/2024
 
 
TXT Orphan Status for Sickle Cell Disease Drug
10/25/2024
 
 
TXT Support for Biosimilar Product Class Guidances
10/24/2024
 
 
TXT Panel To Discuss 503A Bulk Drug Additions
10/24/2024
 
 
TXT Intellia Reports Positive Data on Gene Therapy
10/24/2024
 
 
TXT Probe Leqembi, Kisunla Trials: Public Citizen
10/24/2024
 
 
TXT Baxter Class 1 Recall of Life2000 Ventilator
10/24/2024
 
 
TXT Researchers Find Alzheimer’s Potential in Semaglutide
10/24/2024
 
 
TXT ASHP Sees 277 Active Drug Shortages
10/24/2024
 
 
TXT Safety Alert on Regener-Eyes Eye Drops
10/24/2024
 
 
TXT Alto Neuro Depression Study Fails
10/23/2024
 
 
TXT Pinnacle Making Illegal Amniotic Products: FDA
10/23/2024
 
 
TXT Add Semaglutide to DDC Lists: Novo Nordisk
10/23/2024
 
 
TXT FDA Approves Expanded Abrysvo Indication
10/23/2024
 
 
TXT CA Man Pleads Guilty to Selling Unapproved Drugs
10/23/2024
 
 
TXT U.P. Oncolytics Gets Orphan Status for Glioma Therapy
10/23/2024
 
 
TXT FDA to Study Adherence and Patient Preference in Ads
10/23/2024
 
 
TXT AI Forcing FDA to ‘Rethink Everything’: Califf
10/23/2024
 
 
TXT Issues Found in BIMO Clinical Site Inspection
10/22/2024
 
 
TXT Amnio Technology Illegally Marketing Amniotic Products: FDA
10/22/2024
 
 
TXT Otsuka Reports Interim Data on Sibeprenlimab
10/22/2024
 
 
TXT Acromegaly NDA Hit with Complete Response Letter
10/22/2024
 
 
TXT Drug Interaction Labeling Guidance
10/22/2024
 
 
TXT It’s Official: Tarver Takes on CDRH Director Post
10/22/2024
 
 
TXT New FDA Data Tool on Parkinson’s
10/22/2024
 
 
TXT 3 Stakeholders Nix Biosimilar PSGs
10/22/2024
 
 
TXT Digital Health Advisory Committee AI Meeting Materials
10/22/2024
 
 
TXT Lenz Therapeutics NDA Accepted for Farsightedness
10/21/2024
 
 
TXT Novo Nordisk to Seek Rybelsus Expanded Label
10/21/2024
 
 
TXT NDA for Liver Cancer Combo Therapy Resubmitted
10/21/2024
 
 
TXT FDA Clears Design Changes to Zio AT
10/21/2024
 
 
TXT 18 State Attorneys General Support Mifepristone Ruling
10/21/2024
 
 
TXT House GOPers Seek IG Probe on FDA Lab Safety
10/21/2024
 
 
TXT BioNTech Partial Hold on Lung Cancer Trial
10/18/2024
 
 
TXT Guide on Post-Op Nausea Drug Development
10/18/2024
 
 
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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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