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 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 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 More Support for Treating All Biologics the Same
09/25/2024
 
 
TXT FDA OKs AZ’s Tagrisso Lung Cancer Drug
09/25/2024
 
 
TXT Lilly Sues FDA Over Retatrutide Designation
09/25/2024
 
 
TXT Azurity Selling Unapproved Drugs: FDA
09/24/2024
 
 
TXT ODAC Discussing Immune Checkpoint Inhibitors
09/24/2024
 
 
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 Topside Change at CDRH Continues its Corruption
09/23/2024
 
 
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 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 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 Trump Aligned Group Sues FDA on Ivermectin
12/11/2023
 
 
TXT Guide on DTC Quantitative Efficacy/Risk Info
12/11/2023
 
 
TXT Device CEO Pleads Guilty in Covid Test Scheme
12/11/2023
 
 
TXT FDA Requiring Less Burdensome Isotretinoin REMS
12/11/2023
 
 
TXT NDA Resubmission on Hypoparathyroidism Accepted
12/11/2023
 
 
TXT PETA Letter Hits at FDA Lab Animal 'Cruelty'
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