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FDA-RELATED NEWS
 
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TXT CBER Staff Guide on IND Processing, Review
07/10/2024
 
 
TXT Change Device Enforcement Guide: AdvaMedDx
07/10/2024
 
 
TXT Payers Should Help in Evidence Generation: Report
07/10/2024
 
 
TXT Arcutis Biotherapeutics’ Zoryve OK’d for Atopic Dermatitis
07/10/2024
 
 
TXT Regenerative Medicine Designation for Alzheimer’s Therapy
07/10/2024
 
 
TXT CGMP Violations at S. Korea’s ReBom Co.
07/09/2024
 
 
TXT Inspire Recalls Implantable Pulse Generator
07/09/2024
 
 
TXT Optikem CGMP Violations Cited
07/09/2024
 
 
TXT CBER Updates 2024 Guidance Agenda
07/09/2024
 
 
TXT Elevar Resubmitting Cancer Drug NDA
07/09/2024
 
 
TXT 30 1st Quarter Serious Risk Signals
07/09/2024
 
 
TXT FDA OKs Cordis Vascular Closure Device
07/09/2024
 
 
TXT Don’t Use Medtronic NIM EMG Endotracheal Tubes: FDA
07/09/2024
 
 
TXT UniQure Seeking Accelerated Approval Path for Gene Therapy
07/09/2024
 
 
TXT Philips Recalls Sense XL Torso MRI Coils
07/08/2024
 
 
TXT Groups Want Changes in Drug Labeling Guidance
07/08/2024
 
 
TXT Magellan Guilty Plea Over Misbranded Devices
07/08/2024
 
 
TXT Checkpoint Resubmits Cosibelimab BLA
07/08/2024
 
 
TXT FDA OKs Pyzchiva as Stelara Biosimilar
07/08/2024
 
 
TXT FDA OKs Genentech’s Vabysmo Syringe
07/08/2024
 
 
TXT FDA Drops Interchangeability Switching Studies
07/08/2024
 
 
TXT CGMP Violations in Sun Pharmaceutical Inspection
07/08/2024
 
 
TXT Opportunities, Risks in SCOTUS End to Chevron Deference: Lawyers
07/08/2024
 
 
TXT Web Site Illegally Selling Semaglutide Products: FDA
07/08/2024
 
 
TXT FDA OKs New Lilly Alzheimer’s Drug
07/08/2024
 
 
TXT Plan Now to Adopt FDA Trial Diversity Guide: Lawyers
07/08/2024
 
 
TXT ICH M14 Pharmacoepidemiological Studies Guide
07/08/2024
 
 
TXT Device Total Product Life Cycle Advisory Program Continues
07/08/2024
 
 
TXT Guidance on Addressing Regulated Product Misinformation
07/08/2024
 
 
TXT Guide on Combo Product Risk Analyses
07/08/2024
 
 
TXT FDA WEBVIEW CLOSED JULY 4TH WEEK
06/29/2024
 
 
TXT Brookfield Medical/Surgical FDA-483
06/28/2024
 
 
TXT Complete Response on Rocket Gene Therapy
06/28/2024
 
 
TXT Praise for Biological Labeling Draft Guidance
06/28/2024
 
 
TXT Drug Delivery Device Guidance
06/28/2024
 
 
TXT Philips Updates BiPAP Ventilator Use Instructions
06/28/2024
 
 
TXT SCOTUS Chevron Decision Harms the Public: Coalition
06/28/2024
 
 
TXT Abbott Recalls HeartMate System Monitor
06/28/2024
 
 
TXT 6 Observations in Cipla FDA-483
06/27/2024
 
 
TXT FDA Opening Office in Rwanda
06/27/2024
 
 
TXT FDA Modifies CAR T Cell REMS
06/27/2024
 
 
TXT Draft Guide on Diversity Action Plans
06/27/2024
 
 
TXT Complete Response on BLA for Lung Cancer Combo
06/27/2024
 
 
TXT Schakowsky Introduces Drug Import Bill
06/27/2024
 
 
TXT START Pilot Helps Rare Disease Treatments: Cavazzoni
06/27/2024
 
 
TXT Torrent Pharmaceuticals FDA-483
06/27/2024
 
 
TXT FDA De Novo Authorization for Hep C Test
06/27/2024
 
 
TXT Guidance on Study Underrepresentation Diversity Plans
06/26/2024
 
 
TXT Verona Gets Ohtuvayre Approval for COPD
06/26/2024
 
 
TXT BrainStorm Gets FDA Alignment on CMC Issues
06/26/2024
 
 
TXT CDRH Joins Gates Foundation on Analytic Methods
06/26/2024
 
 
TXT Tempus AI Device for Atrial Fibrillation
06/26/2024
 
 
TXT Public Citizen Ideas to Improve Advisory Committees
06/26/2024
 
 
TXT 14 Submissions with RWE in FY 2023: FDA
06/26/2024
 
 
TXT Sani-Care Salon Products CGMP Violations
06/25/2024
 
 
TXT HCTP Violations at Indiana Lions Eye Bank
06/25/2024
 
 
TXT NDRP Modernization Successes Lead to ‘Permanent Initiative’
06/25/2024
 
 
TXT AdvaMed Concerned with Device Remanufacturing Guide
06/25/2024
 
 
TXT Regeneron Urges New Guidances for Precision Medicine
06/25/2024
 
 
TXT Biden Pressured FDA for Pfizer Covid Vaccine: House Report
06/25/2024
 
 
TXT 2nd Complete Response on AbbVie Parkinson’s Drug
06/25/2024
 
 
TXT Rexulti/Sertraline Combo NDA for PTSD
06/25/2024
 
 
TXT Vyvgart Hytrulo OK’d for Demyelinating Polyneuropathy
06/24/2024
 
 
TXT Workshop in User Fee Meeting Management
06/24/2024
 
 
TXT Device Consensus Standards Modifications
06/24/2024
 
 
TXT Invega Not Withdrawn Due to Safety/Efficacy
06/24/2024
 
 
TXT Janssen’s TB Drug Converted to Full Approval
06/24/2024
 
 
TXT Small Entity Compliance Guide on LDT Phase-out
06/24/2024
 
 
TXT Endotronix Pulmonary Artery Sensor Approved
06/24/2024
 
 
TXT Committee Finds Troubling Foreign Inspection Issues
06/24/2024
 
 
TXT FDA Denies Petition Seeking Wakix Withdrawal
06/24/2024
 
 
TXT Lexicon Refiles NDA for Sotagliflozin
06/21/2024
 
 
TXT Déjà vu: Marks Overrides Reviewers on Duchenne Drug Again
06/21/2024
 
 
TXT Zoll Recalls Ventilators Over Operator Guides
06/21/2024
 
 
TXT Guide on Adulteration when Inspection Refused
06/21/2024
 
 
TXT Workshop on NDA/BLA Meeting Management Practices
06/21/2024
 
 
TXT Lilly’s Files Mounjara NDA for Sleep Apnea
06/21/2024
 
 
TXT Clinical Hold Lifted on Huntington’s Drug
06/20/2024
 
 
TXT FDA OKs ‘Major’ Yescarta, Tecartus REMS Changes
06/20/2024
 
 
TXT 4 Observations in Dr. Reddy’s Inspection
06/20/2024
 
 
TXT Inspection Delay, Denial, Limit, Refusal Guidance
06/20/2024
 
 
TXT FDA Abandoning Biosimilar Switching Studies
06/20/2024
 
 
TXT J&J Seeks Tremfya Crohn’s Indication
06/20/2024
 
 
TXT De Novo for Onkos Implant Antibacterial Coating
06/20/2024
 
 
TXT Synapse Labs Studies ‘Unacceptable’: FDA
06/20/2024
 
 
TXT Praise, Suggestions for RWE Studies Guidance
06/20/2024
 
 
TXT Clinical Hold on Zentalis Drug After 2 Deaths
06/18/2024
 
 
TXT Elixir Breakthrough Status for Coronary Bioadapter
06/18/2024
 
 
TXT Akili OTC App Cleared for ADHD
06/18/2024
 
 
TXT 2023 Trial Diversity Workshop Report
06/18/2024
 
 
TXT Animal Drug User Fee Educational Conference
06/18/2024
 
 
TXT Former Device Company CEO Gets 6 Years in Prison
06/18/2024
 
 
TXT FDA Asks Input on Non-Device Software Functions, Impacts
06/18/2024
 
 
TXT Protein Data Bank Aided 100% of Targeted Cancer Drugs: Study
06/18/2024
 
 
TXT Truqap Misses Endpoints in Breast Cancer Trial
06/18/2024
 
 
TXT FDA WEBVIEW CLOSED 6/19 FOR JUNETEENTH
06/18/2024
 
 
TXT Partial Hold on BioNTech/Medilink Trial
06/17/2024
 
 
TXT Keytruda/Chemo Approved for Endometrial Cancer
06/17/2024
 
 
TXT Guide on Diabetic Foot Infection Drugs
06/17/2024
 
 
TXT Generic Drug Facility Readiness Inspection Guide
06/17/2024
 
 
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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;
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  • Summaries of the latest Warning Letters;
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  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
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