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  13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Next >>
 
TXT Expanded Indication for Abbott Heart Catheter
02/02/2023
 
 
TXT Fraudulent Contract Research Org. Leads to Debarment
02/02/2023
 
 
TXT Glucosamine Case Can Inform Drug, Device Cases: Attorney
02/02/2023
 
 
TXT M13A Bioequivalence Consensus Guideline
02/01/2023
 
 
TXT Positive Covid Test Requirement Lifted on 2 Therapeutics
02/01/2023
 
 
TXT No Justification for Lexicon Hearing: CDER
02/01/2023
 
 
TXT CDER Planning 98 New, Revised Guidances for 2023
02/01/2023
 
 
TXT Lyme Disease Drug Development Guidance
02/01/2023
 
 
TXT IBSA Recalls Some Tirosint-Sol Lots
02/01/2023
 
 
TXT Clarius Mobile’s Musculoskeletal AI Measurer
02/01/2023
 
 
TXT Xenex Files De Novo for Disinfection Device
02/01/2023
 
 
TXT RightEye Promoting Off-Label Use: FDA
01/31/2023
 
 
TXT Multiple Violations at Adept Life Science
01/31/2023
 
 
TXT GDUFA 2022 Science and Research Report
01/31/2023
 
 
TXT Improve Biosimilar Development and Approval Efficiency
01/31/2023
 
 
TXT Externally Controlled Trial Guidance
01/31/2023
 
 
TXT FDA 'Defying' Appeals Court is Troubling: Attorneys
01/31/2023
 
 
TXT CBER 2023 Guidance Agenda
01/31/2023
 
 
TXT Biden Administration Ending Public Health Emergency 5/11
01/31/2023
 
 
TXT CBER Tissues/Advanced Therapies Director Bryan Retiring
01/31/2023
 
 
TXT Califf Proposes ‘Transformation’ of Foods Program, ORA
01/31/2023
 
 
TXT Class 1 Recall of Smiths CADD Infusion Sets
01/31/2023
 
 
TXT Guide on Lasers for Surveying, Leveling and Aligning
01/30/2023
 
 
TXT Class 1 Recall of Medtronic ‘Leaky’ Catheters
01/30/2023
 
 
TXT Guide on Acromegaly Drug Development
01/30/2023
 
 
TXT Consent Decree Against LGM Pharma
01/30/2023
 
 
TXT CDER/CBER Restarting In-Person Industry Meetings
01/30/2023
 
 
TXT Oracle Technology Guru Named FDA Digital Health Director
01/30/2023
 
 
TXT Lawsuit Against FDA and Livestock/Poultry Antibiotic Use
01/27/2023
 
 
TXT FDA Funding Opportunity for Pediatric Device Consortia
01/27/2023
 
 
TXT New Data Support Carvykti sNDA in Multiple Myeloma
01/27/2023
 
 
TXT Vanda Petitions FDA Over Teva ‘Non-Braille’Labeling
01/27/2023
 
 
TXT FDA Denies Petition on Jakafi Safety Labeling
01/27/2023
 
 
TXT Eschoo Reelected as Ranking Dem on Health Subcommittee
01/27/2023
 
 
TXT LivaNova Again Recalls LifeSPARC Controller Over Software
01/27/2023
 
 
TXT Rep. Guthrie to Chair FDA Oversight Committee
01/26/2023
 
 
TXT FDORA Requires Trial Diversity Action Plans: Attorneys
01/26/2023
 
 
TXT New CBD Regulatory Framework Needed: Woodcock
01/26/2023
 
 
TXT Biological Therapies Need Clinical Trials: Califf, Marks
01/26/2023
 
 
TXT Include all Media in Drug Promotion Regs: Professors
01/26/2023
 
 
TXT CDRH OK’d 19 Breakthrough Devices in 2022
01/26/2023
 
 
TXT Dental Practices Defrauded FDA: Justice Dept.
01/26/2023
 
 
TXT Torrent Inspection Classified as Official Action Indicated
01/26/2023
 
 
TXT No Evidence of Contaminated Cough Syrup in U.S.: FDA
01/26/2023
 
 
TXT Panel Backs Plan to Harmonize Covid Vaccine Composition
01/26/2023
 
 
TXT Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions
01/25/2023
 
 
TXT Final Guide on Compounding Ibuprofen Suspensions
01/25/2023
 
 
TXT Cardiosave Intra-Aortic Balloon Pumps Recalled
01/25/2023
 
 
TXT Improving Myelodysplastic Syndromes Trials
01/25/2023
 
 
TXT FDA Lifts Hold on Inhibikase Parkinson’s Trial
01/25/2023
 
 
TXT BsUFA Regulatory Research Roadmap
01/25/2023
 
 
TXT FDA/Aetion Oncology RWD Research
01/25/2023
 
 
TXT GenBioPro Sues to Overturn WV Abortion Pill Law
01/25/2023
 
 
TXT Merck Ending Keytruda Phase 3 Prostate Cancer Trial
01/25/2023
 
 
TXT Panel Votes to Approve Cidara’s Rezafungin
01/25/2023
 
 
TXT ‘7 Deadly Sins’ at FDA Presentations: Mikkael Sekeres
01/24/2023
 
 
TXT Biogen’s Lou Gehrig’s NDA Heads to Panel Review
01/24/2023
 
 
TXT AdvaMed Device Sterilization Reg Proposals for EPA
01/24/2023
 
 
TXT Lobbying Killed VALID Act: ProPublica
01/24/2023
 
 
TXT Many Advertised Drugs Have Low Therapeutic Value: Study
01/24/2023
 
 
TXT ‘Objectionable Conditions’ in Larkin Hospital IRB
01/24/2023
 
 
TXT ‘Corrective Recall’ Asked for Hemodialysis Units
01/24/2023
 
 
TXT 2022 FDA Advertising, Promotion Enforcement Reviewed
01/24/2023
 
 
TXT FDA Backs Status Quo in Orphan Drug Exclusivity
01/23/2023
 
 
TXT FDA Moving to Annual Covid Strain Selection Like Flu
01/23/2023
 
 
TXT FDA Releases Cannabis Clinical Research Guidance
01/23/2023
 
 
TXT DePuy Synthes Pays $10 Million to Settle Kickback Scheme
01/23/2023
 
 
TXT Petition Urges FDA to Regulate LED-pulsing Devices
01/23/2023
 
 
TXT Advertising Group Hits Novartis on Kisqali DTC Ad
01/23/2023
 
 
TXT Guidance on Ibuprofen Compounding to Help Shortages: FDA
01/20/2023
 
 
TXT FDA Memo Recommends Califf Order Makena’s Withdrawal
01/20/2023
 
 
TXT Medtronic Recalls Extended to More HeartWare Batteries
01/20/2023
 
 
TXT Panel to Discuss Opioid Postmarketing Requirement
01/20/2023
 
 
TXT FDA Lifts Clinical Hold on Pompe Gene Therapy
01/20/2023
 
 
TXT ICH Quality Risk Management Guide Adopted by FDA
01/20/2023
 
 
TXT Mend Lax Clinical Trial Reporting: Pallone
01/19/2023
 
 
TXT FDA Denies Fresenius Glycopyrrolate Petition
01/19/2023
 
 
TXT Contrast Agent, Radioactive Drug, OTC Drug Status Clarified
01/19/2023
 
 
TXT Conformity Assessment Program Information Collection
01/19/2023
 
 
TXT Surmodics SurVeil PMA ‘Not Approvable’: FDA
01/19/2023
 
 
TXT FDA Amends, Repeals Some Rad Health Regs
01/19/2023
 
 
TXT FDA Seeks Injunction Against LGM Pharma
01/19/2023
 
 
TXT 11 Observations on Intas Pharmaceuticals FDA-483
01/19/2023
 
 
TXT Realize Medical Virtual Reality Surgical Tool Cleared
01/19/2023
 
 
TXT Fix the Evidence Generation System Now: Califf
01/19/2023
 
 
TXT Stakeholder Suggestions for IHC Q5A Guidance
01/18/2023
 
 
TXT FDA Denies Petition on Gabapentin Scheduling
01/18/2023
 
 
TXT FDA Wants RWD User Fee Funding Comments
01/18/2023
 
 
TXT Janssen Ending Mosaico HIV Vaccine Trial
01/18/2023
 
 
TXT Deny Mifepristone Preliminary Injunction: FDA
01/18/2023
 
 
TXT Moderna to Seek RSV Vaccine OK
01/18/2023
 
 
TXT Improve HHS Oversight of Pathogen Research: GAO
01/18/2023
 
 
TXT CDER Continuing QMM Program Development
01/18/2023
 
 
TXT Improve FDA Management of IT Contracts: OIG
01/17/2023
 
 
TXT BsUFA 3 Changes Described
01/17/2023
 
 
TXT Woman Sentenced in Drug Trial False Statement Case
01/17/2023
 
 
TXT Appeals Court Nixes Sandoz Generic Aubagio Suit
01/17/2023
 
 
TXT Sterile Drug Issues at Optum Infusion
01/17/2023
 
 
TXT FDA Expands CN Bio Collaboration
01/17/2023
 
 
TXT Diagnostics, Dietary Supplement Reforms on FDA Legislative Agenda
01/17/2023
 
 
<< Prev  13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30  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