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FDA-RELATED NEWS
 
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TXT Graft-vs-Host Product Development Guidance
09/28/2023
 
 
TXT FDA OKs Pfizer’s Bosulif for Pediatric CML
09/27/2023
 
 
TXT Ileus Added to Ozempic Label Adverse Effects
09/27/2023
 
 
TXT Gilead Ends AML Trial of Magrolimab
09/27/2023
 
 
TXT Prescription Information Modernization Bill
09/27/2023
 
 
TXT Boston Scientific’s AVVIGO+ Guidance Device Cleared
09/27/2023
 
 
TXT Peace Wellness Marketing Tissue Products: FDA
09/27/2023
 
 
TXT Philips Hid Breathing Machine Complaints: Report
09/27/2023
 
 
TXT Nephron Pharma Hit Again with FDA-483
09/27/2023
 
 
TXT Device QS Cybersecurity Guidance
09/26/2023
 
 
TXT FDA Rejects Anti-Sweating Gel
09/26/2023
 
 
TXT FDA Pushing EG, DEG Testing
09/26/2023
 
 
TXT Guilty Plea in Adulterated HIV Meds Case
09/26/2023
 
 
TXT FDA ‘Cut Corners’ to Approve Hetlioz ANDA: Vanda
09/26/2023
 
 
TXT Upcoming CBER Changes Explained
09/26/2023
 
 
TXT Drug Use Software Guidance Analyzed by Attorneys
09/26/2023
 
 
TXT Novartis Touts Positive Lutathera Phase 3 Data
09/25/2023
 
 
TXT FDA Reviewers Dismiss ALS Therapy Benefit
09/25/2023
 
 
TXT FDA Clears Profound Medical Ablation Module
09/25/2023
 
 
TXT VistaPharm Recalls Sucralfate Lot
09/25/2023
 
 
TXT Coherus Gets Complete Response on Udenyca
09/25/2023
 
 
TXT Manufacturing Resumes at Damaged Pfizer Site
09/25/2023
 
 
TXT FDA Releases Novo Nordisk FDA-483
09/22/2023
 
 
TXT Government, FDA Shutdown Appearing More Likely
09/22/2023
 
 
TXT Guide on Inspection Alternative Tools
09/22/2023
 
 
TXT Senators Urge FDA to Strengthen Opioid Studies
09/22/2023
 
 
TXT Legislation Introduced to Improve Device Recalls
09/22/2023
 
 
TXT Panel Votes Down Intarcia Diabetes Implant
09/22/2023
 
 
TXT PDUFA Formal Meeting Guidance
09/21/2023
 
 
TXT Drug Manufacturing Alternative Assessment Tools
09/21/2023
 
 
TXT Guidance on ISO-10993-1 Explained
09/21/2023
 
 
TXT Ozempic Mental Health Issues Up: NPR
09/21/2023
 
 
TXT Merck sBLA for Keytruda Use in Cervical Cancer
09/21/2023
 
 
TXT Orphan Drug Designation for Puma’s Alisertib
09/21/2023
 
 
TXT FDA Dismisses Novo Nordisk Inspection Concerns
09/21/2023
 
 
TXT ‘Major Disruption’ Clinical Trial Guidance
09/20/2023
 
 
TXT Industry Fights FDA on Drug Shortage Fixes: Califf
09/20/2023
 
 
TXT FDA Reviewers Again Nix Intarcia Diabetes Product
09/20/2023
 
 
TXT Drug Preemption Defense Demanding, Attainable: Attorneys
09/20/2023
 
 
TXT Taysha Discontinues Gene Therapy Program
09/20/2023
 
 
TXT UCB Faces Another Review Delay on Bimekizumab
09/20/2023
 
 
TXT FDA Recalls Saline Solution
09/20/2023
 
 
TXT CRL for ARS Pharmaceuticals’ Neffy
09/20/2023
 
 
TXT Kimera Labs Illegally Marketing Exosomes: FDA
09/19/2023
 
 
TXT CDRH International Harmonization Plan
09/19/2023
 
 
TXT More 510(k) Changes Likely: Attorneys
09/19/2023
 
 
TXT FDA Converts ASCA from Pilot to Permanent
09/19/2023
 
 
TXT Houston Man Sentenced in Counterfeit Drugs Case
09/19/2023
 
 
TXT Vanda Hetlioz Dispute with FDA Heats Up
09/19/2023
 
 
TXT CGMP, Other Violations at PureChemPros
09/19/2023
 
 
TXT Breakthrough for Parkinson’s Neurostimulator
09/19/2023
 
 
TXT English Doctor Attacks FDA/CDC Covid Vaccine Data
09/18/2023
 
 
TXT Drug Use-related Software Labeling Guide
09/18/2023
 
 
TXT Substantial Evidence from 1 Trial Guidance
09/18/2023
 
 
TXT Petition Denied on Tacrolimus Bioequivalence
09/18/2023
 
 
TXT Vision Patient-reported Outcomes Workshop
09/18/2023
 
 
TXT Novo Nordisk Gets FDA-483: Reports
09/18/2023
 
 
TXT FDA Extends BLA Review of Melanoma Therapy
09/15/2023
 
 
TXT Digital Health Frequently Asked Questions
09/15/2023
 
 
TXT Beacon Biosignals 510(k) for Sleep Monitor
09/15/2023
 
 
TXT FDA OKs GSK’s Blood Cancer Drug
09/15/2023
 
 
TXT Draft Guide on Biosimilar/Interchangeable Labeling
09/15/2023
 
 
TXT Voluntary Improvement Program Guidance
09/14/2023
 
 
TXT Breakthrough Devices Updated Final Guidance
09/14/2023
 
 
TXT Forms FDA 3988 and 3989 Guidance
09/14/2023
 
 
TXT AI is FDA Info Technology Plan’s Top Goal
09/14/2023
 
 
TXT FDA 2 Weight Loss Device Guidances
09/14/2023
 
 
TXT FTC Warns on Improper Orange Book Patent Listings
09/14/2023
 
 
TXT FDA Clarifies Safety of Phenylephrine Products
09/14/2023
 
 
TXT FDA, Rocket Agree on Phase 2 Danon Disease Trial
09/13/2023
 
 
TXT Safety Concerns Stop Eiger Phase 3 Hepatitis Trial
09/13/2023
 
 
TXT Supremes May Hear Label Preemption Case: Attorneys
09/13/2023
 
 
TXT Include ICH Q12 in Gene Therapy Guidance: ISPE
09/13/2023
 
 
TXT White House Credits FDA on Drug Shortages
09/13/2023
 
 
TXT Abbott Recalls Proclaim Pulse Generators
09/13/2023
 
 
TXT ‘Good Cause’ Guidance Needs Flexibility: PhRMA
09/13/2023
 
 
TXT Bipartisan Legislation on Patent Listings
09/13/2023
 
 
TXT FDA Questions Efficacy of Patisiran sNDA
09/12/2023
 
 
TXT FY 2022 GDUFA Science, Research Outcomes
09/12/2023
 
 
TXT Safecor Health CGMP Violations
09/12/2023
 
 
TXT Similasan Marketing Unapproved New Drugs: FDA
09/12/2023
 
 
TXT FDA Warns 8 Firms for Unapproved Eye Drugs
09/12/2023
 
 
TXT CDER Defends Pepaxto Withdrawal Proposal
09/12/2023
 
 
TXT 2 FDA Recommendations in Patient Safety Report
09/12/2023
 
 
TXT White Paper on Preventing Drug Shortages
09/12/2023
 
 
TXT Panel Votes Down OTC Cold Ingredient
09/12/2023
 
 
TXT Mallinckrodt Recalls One-Way Ventilator Valve
09/12/2023
 
 
TXT Jury Convicts 2 for Clinical Trial Fraud
09/12/2023
 
 
TXT FDA Permanently Debarring Tatsene
09/12/2023
 
 
TXT 45 Device Alerts Issued in 2022: FDA
09/11/2023
 
 
TXT Justice Petitions Supreme Court Over Mifeprex
09/11/2023
 
 
TXT Updated Covid-19 Vaccines Approved by FDA
09/11/2023
 
 
TXT Tagrisso Phase 3 Data in Lung Cancer
09/11/2023
 
 
TXT Guide on Peptide Clin-Pharm Considerations
09/11/2023
 
 
TXT CMC Readiness Pilot Program
09/11/2023
 
 
TXT Novartis Recalls Sandimmune Lot
09/11/2023
 
 
TXT FDA Updates Alert on Halyard N95 Masks
09/08/2023
 
 
TXT Senators Reintroduce Opioid Studies Bill
09/08/2023
 
 
TXT House Committee Hearing on Drug Shortages
09/08/2023
 
 
TXT Subcutaneous Tecentrig Delayed Due to CMC Info
09/08/2023
 
 
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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;
  • 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