FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
<< Prev  7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Next >>
 
TXT FDA Corrects ANDA Approval Withdrawals from 6/21
09/13/2024
 
 
TXT Expanded Approval for Dupixent in Rhinosinusitis
09/13/2024
 
 
TXT Lilly’s Ebglyss Approved for Eczema
09/13/2024
 
 
TXT FDA Clears SamanTree’s Histolog Scanner
09/13/2024
 
 
TXT Genentech’s Ocrevus Zunovo Approved for MS
09/13/2024
 
 
TXT Senators Introduce Bill to Reduce Animal Testing
09/13/2024
 
 
TXT Feedback Sought on Integrated Review Document
09/12/2024
 
 
TXT FDA Publishes 8th Revision of Electronic Format Guide
09/12/2024
 
 
TXT Apple AirPods Hearing Software Authorized
09/12/2024
 
 
TXT Tremfya Secures Approval for Ulcerative Colitis
09/12/2024
 
 
TXT Gilead Positive on Twice-Yearly HIV Drug Data
09/12/2024
 
 
TXT GSK Moves mRNA Flu Vaccine to Phase 3
09/12/2024
 
 
TXT FDA Veozah Liver Injury Warning
09/12/2024
 
 
TXT Recommendations on Rare Disease Collaboration
09/12/2024
 
 
TXT GDUFA ANDA Amendment Submissions
09/11/2024
 
 
TXT OPDP Hits AbbVie Over Serena Williams DTC Ad
09/11/2024
 
 
TXT 3 FDA Innovative Manufacturing Action Steps
09/11/2024
 
 
TXT FDA Warns 2 Chinese Labs About Data Concerns
09/11/2024
 
 
TXT Lawsuit Against FDA Dismissed on Ripeness Grounds
09/11/2024
 
 
TXT Ocaliva Confirmatory Trial Fails: FDA
09/11/2024
 
 
TXT CDER Quantitative Medicine CoE Explained
09/11/2024
 
 
TXT Follow FDA Online Misinformation Guidance: Attorneys
09/10/2024
 
 
TXT DeepWell Digital Software Cleared for Stress Relief
09/10/2024
 
 
TXT CGMP Violations at Zydus Lifesciences Facility
09/10/2024
 
 
TXT Multiple Optikem International Violations Cited
09/10/2024
 
 
TXT Changes Sought in FDA Misinformation Guidance
09/10/2024
 
 
TXT FDA Clears Sonic Incytes’ Velacur Device
09/10/2024
 
 
TXT FDA Mulls More Post-Inspection Feedback: Cavazzoni
09/10/2024
 
 
TXT CBER Updates Refusal-to-File Procedure
09/09/2024
 
 
TXT GSK Highlights Depemokimab Asthma Data
09/09/2024
 
 
TXT Hold Removed on Rezolute Hypoglycemia Drug
09/09/2024
 
 
TXT Femasys Fallopian Tube Diagnostic Cleared
09/09/2024
 
 
TXT Lab Group Seeks Congress’ Help on LDT Rule
09/09/2024
 
 
TXT Travere’s Filspari Converted to Full Approval
09/06/2024
 
 
TXT Panel to Review Stealth Bio Barth Syndrome NDA
09/06/2024
 
 
TXT GSK Reports Trial Results of Nucala in COPD
09/06/2024
 
 
TXT Odin Medical AI Colon Polyp Detector
09/06/2024
 
 
TXT Eye Product Manufacturer Hit with Warning Letter
09/06/2024
 
 
TXT Biocon Biologics Gets 10-item FDA-483
09/06/2024
 
 
TXT Patient Preference Info in Product Life Cycle
09/05/2024
 
 
TXT Medtronic Laryngoscope Recall is Class 1
09/05/2024
 
 
TXT Glenmark Pays $25 Million in False Claims Case
09/05/2024
 
 
TXT Breas Medical Recalls Vivo 45 LS Ventilators
09/05/2024
 
 
TXT Lilly Reports Positive Data in Weekly Insulin Trials
09/05/2024
 
 
TXT FDA ‘Overdue’ on 2,000 Drug Plant Inspections: AP
09/05/2024
 
 
TXT Committee to Consider Iterum Sulopenem NDA
09/05/2024
 
 
TXT Group Seeks Clarity on Use-Related Risk Analyses
09/05/2024
 
 
TXT Drug Nitrosamine Impurity Control Guidance
09/04/2024
 
 
TXT Baxter Recalls Volara Circuits, Adapter
09/04/2024
 
 
TXT Comments on ICH RWD Studies Guidance
09/04/2024
 
 
TXT Labs Ask Court to Throw Out FDA’s LDT Rule
09/04/2024
 
 
TXT SoloVital Illegally Marketing Hyaluronic Acid: FDA
09/04/2024
 
 
TXT California Man Pleads Guilty to Illegal Etizolam Sales
09/04/2024
 
 
TXT Vanda Sues FDA Over Pending Tradipitant NDA Decision
09/04/2024
 
 
TXT Otsuka Pharmaceutical FDA-483 Released
09/03/2024
 
 
TXT FDA Clears Embecta Disposable Insulin Patch Pump
09/03/2024
 
 
TXT Atlanta Doctor’s Research Didn’t Follow Plan: FDA
09/03/2024
 
 
TXT Company Illegally Marketing ‘Stem Cells’: FDA
09/03/2024
 
 
TXT PhRMA Wants Changes to Platform Tech Designation
09/03/2024
 
 
TXT Correct ‘Misleading’ AbbVie Study Description: Ali
09/03/2024
 
 
TXT Many Ideas to Approve FDA Regulation of AI: Article
09/03/2024
 
 
TXT FDA Study Analyzes Provider View of Boxed Warnings
09/03/2024
 
 
TXT Guidance on BIMO Data Technical Specifications
09/03/2024
 
 
TXT Syndax Leukemia Review Extended by FDA
07/29/2024
 
 
TXT NEWSROOM CLOSED FOR THE HOLIDAYS
12/18/2023
 
 
TXT FDA OKs Merck Kidney Cancer Drug
12/17/2023
 
 
TXT FDA OKs Glaukos Intraocular Pressure Drug Implant
12/17/2023
 
 
TXT 2 Imbruvica Accelerated Approvals Withdrawn
12/17/2023
 
 
TXT DTC Survey Examines Quantitative Claims
12/17/2023
 
 
TXT FDA Updates Breast Implant Safety Info
12/17/2023
 
 
TXT Guide on Priority Zoonotic Animal Drugs
12/17/2023
 
 
TXT Moderna Inspection Cites GMP Issues: Report
12/17/2023
 
 
TXT FDA Warns Makers of Illegal Animal Antimicrobials
12/14/2023
 
 
TXT FDA in 3 More Collaborative Communities
12/14/2023
 
 
TXT House Committee Threatens FDA Subpoena
12/14/2023
 
 
TXT FDA ‘Doing Little’ on Social Media Drug Claims: Report
12/14/2023
 
 
TXT Pharmasol Permanent Injunction Approved
12/14/2023
 
 
TXT Clinical Hold on 3 CARsgen CAR T-cell Therapies
12/14/2023
 
 
TXT Stakeholder Technical Issues with Ophthalmic Guide
12/14/2023
 
 
TXT FDA Approves Neuroblastoma Drug
12/14/2023
 
 
TXT Update GAO Device Recall Oversight Report: Senators
12/13/2023
 
 
TXT Novid Distributing Unapproved, Misbranded Drug: FDA
12/13/2023
 
 
TXT Guide on Advanced Manufacturing Tech
12/13/2023
 
 
TXT Regulatory Affairs, Foods Program Under Review
12/13/2023
 
 
TXT HELP Committee OKs EFFECTIVE Opioid Bill
12/13/2023
 
 
TXT GOP Senators Urge Increase in Foreign Inspections
12/13/2023
 
 
TXT Amgen Files Priority BLA for Lung Cancer
12/13/2023
 
 
TXT AdvaMed Faults FDA on ‘Safety’ 510(k) Guidances
12/13/2023
 
 
TXT Supreme Court Agrees to Hear Mifepristone Case
12/13/2023
 
 
TXT New Genetic Metabolic Disease Treatment A/C
12/12/2023
 
 
TXT Strengthen Botox Safety Warning: Public Citizen
12/12/2023
 
 
TXT Advanced Manufacturing Technologies Guidance
12/12/2023
 
 
TXT Dolor Tech Settles Over Migraine Device
12/12/2023
 
 
TXT Peptide Clinical Pharmacology Guidance
12/12/2023
 
 
TXT Risk-Based Approach to Therapeutic Protein DDI
12/12/2023
 
 
TXT CDISC Study Tabulation Model Version 3.4
12/12/2023
 
 
TXT FDA May Not be Ready for LDT Rule: Attorney
12/12/2023
 
 
TXT Oncology Drug Dose Optimization Often Deferred: Analysis
12/12/2023
 
 
TXT First Psychedelic NDA Filing Claimed for PTSD Therapy
12/12/2023
 
 
TXT Guide on DTC Quantitative Efficacy/Risk Info
12/11/2023
 
 
<< Prev  7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26  Next >>
 
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
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving