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FDA-RELATED NEWS
 
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TXT Non-Spinal Orthopedic Plate 510(k) Guidance
03/28/2023
 
 
TXT Court Orders Release of FDA Vanda Info
03/28/2023
 
 
TXT IND Not Submitted for Cornea Associates Trials: FDA
03/28/2023
 
 
TXT House Committee Questions FDA Drug Shortage Actions
03/28/2023
 
 
TXT Guide on Animal Studies for Devices
03/28/2023
 
 
TXT Cell, Gene Therapy Application Backlog Questioned
03/28/2023
 
 
TXT Bipartisan Bill on Interchangeable Biologics
03/28/2023
 
 
TXT Labeling Changes Approved for 2 Hedgehog Inhibitors
03/28/2023
 
 
TXT Guide on Animal Studies for Devices
03/27/2023
 
 
TXT Under Protest, Brainstorm Resubmits BLA for NurOwn
03/27/2023
 
 
TXT FDA Resumes Generic Drug In-person Meetings
03/27/2023
 
 
TXT Alternative 510(k) Pathway for Contact Lenses
03/27/2023
 
 
TXT Iovance Biotherapeutics BLA for Melanoma Therapy
03/27/2023
 
 
TXT Two Final Guides on Covid-19 Device Transition
03/24/2023
 
 
TXT Accelerated Approval Guide Pushes Randomized Trials
03/24/2023
 
 
TXT FDA Keeping Close Eye on Social Media Promotion
03/24/2023
 
 
TXT New CDRH Web Page on Diagnostic Data Program
03/24/2023
 
 
TXT Panel Backs Accelerated OK Consideration of Biogen's ALS Drug
03/23/2023
 
 
TXT FDA Digital Health Technologies Framework
03/23/2023
 
 
TXT Xtrava Covid Test Less Effective with Some Variants: FDA
03/23/2023
 
 
TXT Unibody Endografts Don’t Beat Older Ones: Study
03/23/2023
 
 
TXT FDA Reminds on Recalled Exactech Joint Devices
03/23/2023
 
 
TXT Dupixent Meets Key Phase 3 Endpoints: Regeneron
03/23/2023
 
 
TXT Workforce, Education for Regenerative Medicine
03/23/2023
 
 
TXT OSTP Goals for Biotechnology and Biomanufacturing
03/23/2023
 
 
TXT Device Cybersecurity is Top Concern for Shuren
03/23/2023
 
 
TXT Consider Antitrust in Apokyn Generic Case: FTC
03/22/2023
 
 
TXT Complete Response for AbbVie Parkinson’s NDA
03/22/2023
 
 
TXT Registry Set Up for Breast Implant Carcinoma Reports
03/22/2023
 
 
TXT Contradictory Info in P&G Nyquil Filing: FDA
03/22/2023
 
 
TXT Steps Needed to Address Drug Shortages: Report
03/22/2023
 
 
TXT Ways to Increase Clinical Trial Diversity: PhRMA
03/22/2023
 
 
TXT Roche/Lilly Collaborate on Alzheimer’s Test
03/22/2023
 
 
TXT Biological Product Deviation Reports Up: CBER
03/22/2023
 
 
TXT Regulators Need to Keep Up with ‘Patient Influencers’: Study
03/22/2023
 
 
TXT Drug Promotion Research Landscape Analyzed
03/21/2023
 
 
TXT Brainomix AI Stroke Tool Cleared by FDA
03/21/2023
 
 
TXT Viz.ai Algorithm Cleared for Abdominal Aneurysms
03/21/2023
 
 
TXT Sandoz sBLA for Citrate-free Hyrimoz
03/21/2023
 
 
TXT ICH Approves Gene Therapy S12 Guidance
03/21/2023
 
 
TXT Changes Suggested for Cancer Drug Dosing Guidance
03/21/2023
 
 
TXT ‘Significant’ CGMP Violations at Dunagin Pharmaceuticals
03/21/2023
 
 
TXT Multiple Violations at Contract Manufacturer
03/21/2023
 
 
TXT Turn Gene Therapy into Reality: Marks
03/21/2023
 
 
TXT CDER’s Requests for Intarcia Hearing
03/21/2023
 
 
TXT Guide on Pharmacogenomic Data Submissions
03/20/2023
 
 
TXT FDA Input on Rare Disease Development Needed: PhRMA
03/20/2023
 
 
TXT Keep Device Real-World Evidence Under NESTcc: MDMA
03/20/2023
 
 
TXT Athenex Cell Therapy on Clinical Hold
03/20/2023
 
 
TXT Remote Assessments May Be Model for Device Inspections
03/20/2023
 
 
TXT Accelerated Approval Mulled for Biogen’s Tofersen
03/20/2023
 
 
TXT Ipsen NDA Resubmission for Palovarotene
03/17/2023
 
 
TXT Sarepta BLA Needs Panel Review: FDA
03/17/2023
 
 
TXT Guide on Pharmacogenomic Data Submissions
03/17/2023
 
 
TXT FDA Hits Olympus with Warning Letter
03/17/2023
 
 
TXT CDER Posts Annual Office of Compliance Report
03/17/2023
 
 
TXT Datascope’s Cardiosave Heart Pumps Recalled
03/17/2023
 
 
TXT Medical Foods Q&A Guidance
03/16/2023
 
 
TXT Drug Supply Guide on Illegitimate/Suspect Products
03/16/2023
 
 
TXT FDA Clears BD Vaginitis Test
03/16/2023
 
 
TXT Glaxo MenABCWY Vaccine Hits 11 Endpoints
03/16/2023
 
 
TXT IPRP Cell/Gene Therapy Raw Materials Paper
03/16/2023
 
 
TXT Senate Appropriators Announce 4/19 FDA Budget Hearing
03/16/2023
 
 
TXT Panel Votes to Support Paxlovid NDA Approval
03/16/2023
 
 
TXT Community Should Push AA Drug Studies: Califf
03/16/2023
 
 
TXT Clinical Investigation Electronic Systems Guidance
03/15/2023
 
 
TXT Bill to Streamline Generic Drug Approvals
03/15/2023
 
 
TXT Former Drug Sales Rep Pleads Guilty
03/15/2023
 
 
TXT FDA Reviewers Seem Positive on Paxlovid NDA
03/15/2023
 
 
TXT Mixed Stakeholder Views on Orange Book Listings
03/15/2023
 
 
TXT PhRMA Comments on Drug Labeling Guidance
03/15/2023
 
 
TXT Janssen Vaccine Warning on Myocarditis/Pericarditis
03/15/2023
 
 
TXT FDA Clears Telehealth Respiratory Wheeze Detector
03/15/2023
 
 
TXT CGMP Violations at Formology Lab
03/14/2023
 
 
TXT ‘Objectionable Conditions’ at Avanti Study Site: FDA
03/14/2023
 
 
TXT Profounda ‘Significant’ CGMP Violations
03/14/2023
 
 
TXT House GOP Probes Covid ‘Political Interference’ at FDA
03/14/2023
 
 
TXT More Comments on Patent Office/FDA Collaboration
03/14/2023
 
 
TXT Characterizing MRD Data in Cancer Trials
03/14/2023
 
 
TXT Petition Against BD’s Breast Reconstruction Device
03/14/2023
 
 
TXT FDA Clinical Hold on Mersana Tumor Drug
03/13/2023
 
 
TXT Guide on Gastric pH-Dependent Drug Interactions
03/13/2023
 
 
TXT FDA/CDC Correct Florida Official’s Vaccine ‘Misinformation’
03/13/2023
 
 
TXT FDA Webview Reaches Out for Your Guidance
03/13/2023
 
 
TXT FDA Clears PeekMed Orthopedic Surgery Planner
03/13/2023
 
 
TXT Most Drug Shortages are Manufacturing Related: FDA
03/13/2023
 
 
TXT Panel to Review Entasis Therapeutics NDA
03/10/2023
 
 
TXT GAO Report Hits FDA on Advanced Manufacturing Tracking
03/10/2023
 
 
TXT FDA Outlines Disposition of Covid-19 Guidances
03/10/2023
 
 
TXT Pfizer NDA for Migraine Nasal Spray OK’d
03/10/2023
 
 
TXT 18 Senators Want End to Accelerated Approval Pricing Model
03/10/2023
 
 
TXT Baxter Device Correction for Life2000 Ventilator
03/10/2023
 
 
TXT FDA, EMA Parallel Scientific Advice is Effective: Study
03/09/2023
 
 
TXT Lilly Drops Solanezumab on Negative Results
03/09/2023
 
 
TXT How Can FDA Combat Medical Misinformation?
03/09/2023
 
 
TXT FDA Seeks $372 Million (10%) Budget Boost for FY 2024
03/09/2023
 
 
TXT Former Stimwave CEO Indicted
03/09/2023
 
 
TXT FDA Updates EUA Listing for Medical Devices
03/09/2023
 
 
TXT Mesoblast Remestemcel-L BLA Resubmitted
03/08/2023
 
 
TXT Updated Safety Alert on Breast Implant Cancer
03/08/2023
 
 
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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;
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