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FDA-RELATED NEWS
 
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TXT CDRH Portal Update Tracks PMA Submissions
10/04/2024
 
 
TXT Drug-Drug Interaction Assessments Lacking: FDA Research
10/04/2024
 
 
TXT J&J Discontinues Dengue Virus Antiviral Development
10/04/2024
 
 
TXT Medtronic Recalls MiniMed Pumps Over Batteries
10/04/2024
 
 
TXT FDA Clears PlaqueIQ for Cardiovascular Disease
10/04/2024
 
 
TXT Thermo Fisher Plant Scrutinized by FDA: Reuters
10/04/2024
 
 
TXT Tirzepatide Shortage ‘Resolved,’ FDA Says
10/03/2024
 
 
TXT FDA Lifts Hold on Myotonic Dystrophy Drug
10/03/2024
 
 
TXT 5 Observations on BSO FDA-483
10/03/2024
 
 
TXT 18 Potential Signals of Serious Risks/New Safety Info
10/03/2024
 
 
TXT Opdivo Approved for Resectable Lung Cancer
10/03/2024
 
 
TXT FDA Denies Amneal Levothyroxine Petition
10/03/2024
 
 
TXT OrthAlign’s Lantern Hip Handheld Naviation Cleared
10/03/2024
 
 
TXT Aldeyra Refiles NDA for Dry Eye Disease
10/03/2024
 
 
TXT Guide on Study E-Records/Signatures
10/02/2024
 
 
TXT FDA Fast Track for Volastra Ovarian Cancer Drug
10/02/2024
 
 
TXT Lab Groups Seek Summary Judgment in LDT Suit
10/02/2024
 
 
TXT Changes Sought in Device Essential Outputs Guide
10/02/2024
 
 
TXT Philips Respironics Software Correction Class 1: FDA
10/02/2024
 
 
TXT 7 Observations in Annovex Pharma FDA-483
10/02/2024
 
 
TXT Siemens PMA for 3D Mammography Platform OK’d
10/02/2024
 
 
TXT Should FDA Place Hold on Troubled Alzheimer’s Drug?
10/02/2024
 
 
TXT Cassidy Wants Info on Orange Book Listing Requirements
10/01/2024
 
 
TXT Diamond Chemical CGMP Violations
10/01/2024
 
 
TXT FDA Inspections Reorganization Effective 10/1
10/01/2024
 
 
TXT FDA to Study Drug Promotion in Talk Shows
10/01/2024
 
 
TXT Stem Cell Company CEO Gets 36 Months in Jail
10/01/2024
 
 
TXT Fresenius Recalls Ivenix Infusion Pump Software
10/01/2024
 
 
TXT Trial Electronic Systems, Records, Signatures Guide
10/01/2024
 
 
TXT 13 Observations in ProRx FDA-483
10/01/2024
 
 
TXT Kezar Suspends Lupus Trial After 4 Deaths
09/30/2024
 
 
TXT Device Performance Criteria for 4 Dental Devices
09/30/2024
 
 
TXT J&J Files sBLA for Darzalex Faspro
09/30/2024
 
 
TXT Smiths Medical Recalls ParaPac Ventilators
09/30/2024
 
 
TXT Germitec’s Chronos Gets De Novo Marketing Pass
09/30/2024
 
 
TXT FDA Discusses Optimizing Advisory Committees
09/30/2024
 
 
TXT 4 Dental Device Performance Criteria Guides
09/27/2024
 
 
TXT Dupixent Approved for COPD Add On
09/27/2024
 
 
TXT FDA OKs New Schizophrenia Drug
09/27/2024
 
 
TXT Appeals Court Gives FDA a Win on Stem Cells
09/27/2024
 
 
TXT FDA-passed Parkinson’s Drug Part of Falsified Research Probe
09/27/2024
 
 
TXT FDA Full Approval for Lilly’s Retevmo
09/27/2024
 
 
TXT 3 FDA Clinical Trial Guidances Analyzed
09/26/2024
 
 
TXT Pfizer Pulls Oxbryta Sickle Cell Drug
09/26/2024
 
 
TXT Stakeholder Diversity Action Plan Comments
09/26/2024
 
 
TXT Hold Lifted on Biomea Fusion Diabetes Trials
09/26/2024
 
 
TXT Conflict of Interest Seen in Kisunla Approval
09/26/2024
 
 
TXT AbbVie Parkinson’s Trial Meets Endpoints
09/26/2024
 
 
TXT FDA Proposal to Reclassify HBV Assays
09/26/2024
 
 
TXT More Support for Treating All Biologics the Same
09/25/2024
 
 
TXT FDA OKs AZ’s Tagrisso Lung Cancer Drug
09/25/2024
 
 
TXT Info Collection on Device Recall Authority
09/25/2024
 
 
TXT Merck Favezelimab/Keytruda Trial Misses Endpoint
09/25/2024
 
 
TXT FDA Posts 2 FDA-483s
09/25/2024
 
 
TXT Democrat Lawmakers Seek Probe of Shuren Conflicts
09/25/2024
 
 
TXT FDA, CBP Seize Counterfeit Weight Loss Drugs
09/25/2024
 
 
TXT Lilly Sues FDA Over Retatrutide Designation
09/25/2024
 
 
TXT Treat all Biologics the Same: Stakeholders
09/24/2024
 
 
TXT House Passes Pediatric/Rare Disease Bill
09/24/2024
 
 
TXT Eisai Facility FDA-483 Out
09/24/2024
 
 
TXT Arcutis Bio Files sNDA for Zoryve Expanded Use
09/24/2024
 
 
TXT 5 Observations on Hugel FDA-483
09/24/2024
 
 
TXT Braun Introcan Deep Access Catheter Cleared
09/24/2024
 
 
TXT Azurity Selling Unapproved Drugs: FDA
09/24/2024
 
 
TXT ODAC Discussing Immune Checkpoint Inhibitors
09/24/2024
 
 
TXT Korea’s C&T Dream Co. Gets Form-483
09/23/2024
 
 
TXT Gilead Recalls Veklury Over Glass Particle
09/23/2024
 
 
TXT FDA Taps Industry Vet as Device Evaluation Chief
09/23/2024
 
 
TXT Ideaya Bio Plans Phase 3 for Darovasertib
09/23/2024
 
 
TXT Topside Change at CDRH Continues its Corruption
09/23/2024
 
 
TXT FDA OKs 3 New Indications for Bimzelx
09/23/2024
 
 
TXT Zevra’s Niemann-Pick Disease Drug Approved
09/20/2024
 
 
TXT CMC Development and Readiness Pilot
09/20/2024
 
 
TXT 3 FDA Guides on Device Accreditation Scheme for Conformity
09/20/2024
 
 
TXT Sanofi’s Sarclisa OK’d for Multiple Myeloma
09/20/2024
 
 
TXT FDA OKs Rybrevant for Expanded Indication
09/20/2024
 
 
TXT Smiths Recalls ParaPAC Ventilators
09/20/2024
 
 
TXT Vanda Hits FDA for Rejecting Tradipitant
09/19/2024
 
 
TXT Panel to Discuss Seasonal and Avian Flu Preparedness
09/19/2024
 
 
TXT Contaminated Atovaquone Recalled by Bionpharma
09/19/2024
 
 
TXT Medical Device Biocompatibility Guidance
09/19/2024
 
 
TXT RFK Jr. to Recommend Trump Health Agency Heads?
09/19/2024
 
 
TXT CDER Biosim. Interchangeability Change Explained
09/19/2024
 
 
TXT Elanco Gets Anti-Itch Zenrelia Approved for Dogs
09/19/2024
 
 
TXT FDA Hits Spanish Drug Facility with 483
09/19/2024
 
 
TXT Braun Medical Expands Infusion Pump Recall
09/18/2024
 
 
TXT FDA Posts FDA-483s from 2 Indian Companies
09/18/2024
 
 
TXT Firms Seek Broad Extrapolation for Pediatric IBD Dosing
09/18/2024
 
 
TXT Rubio, King Push FDA on Advanced Drug Manufacturing
09/18/2024
 
 
TXT ICER Questions Diversity Action Plan Goal
09/18/2024
 
 
TXT FDA OKs Keytruda Pleural Mesothelioma Indication
09/18/2024
 
 
TXT Bill Introduced on Generic Drug Prompt Approvals
09/18/2024
 
 
TXT FDA Review of Govorestat on Track: Company
09/18/2024
 
 
TXT Fasenra OK’d for Rare Vasculitis
09/18/2024
 
 
TXT Decentralized Clinical Trial Guidance
09/17/2024
 
 
TXT CGMP Violations at TJA Health
09/17/2024
 
 
TXT Quality CDMO Marketing Unapproved Drugs: FDA
09/17/2024
 
 
TXT Consider Phased DSCSA Enforcement: PhRMA
09/17/2024
 
 
TXT Kisqali Expanded Approval for Early Breast Cancer
09/17/2024
 
 
TXT FDA Lifts Partial Clinical Hold on Alzheimer’s Drug
09/17/2024
 
 
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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:
  • 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
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