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FDA-RELATED NEWS
 
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TXT FDA Reviewers Question Amgen’s Lumakras Study
10/03/2023
 
 
TXT AdvaMedDx Challenges Oncology Test Pilot
10/03/2023
 
 
TXT FDA Allows Reformulated Novavax Vaccine
10/03/2023
 
 
TXT Galderma Sent Complete Response Letter
10/03/2023
 
 
TXT Guide on 510(k) eSubmission Template
10/03/2023
 
 
TXT Inspection Derails Lilly Eczema BLA
10/02/2023
 
 
TXT Pilot on ANDA Model-Integrated Evidence
10/02/2023
 
 
TXT Case Study in Corruption: Jeff Shuren’s CDRH
10/02/2023
 
 
TXT Novo Nordisk’s Rivfloza OK’d for Rare Disease
10/02/2023
 
 
TXT FDA Clears AI Heart Failure Detector
10/02/2023
 
 
TXT Government Shutdown Likely This Weekend
09/29/2023
 
 
TXT FDA Proposed Rule on Lab-Developed Tests
09/29/2023
 
 
TXT Graft-versus-Host Disease Guidance
09/29/2023
 
 
TXT De Novo Device E-filing Guide
09/29/2023
 
 
TXT Guide on Drug Dose Banding
09/29/2023
 
 
TXT FDA Approves Biogen’s Actemra Biosimilar
09/29/2023
 
 
TXT Generics Office Expands In-person Meetings
09/29/2023
 
 
TXT De Novo e-Submission Template Guidance
09/28/2023
 
 
TXT Petition Seeks Warning on Fluoroquinolone Guides
09/28/2023
 
 
TXT BrainStorm Cell Therapy Rejected by Panel
09/28/2023
 
 
TXT FDA OKs Amicus Pompe Disease Combo Drugs
09/28/2023
 
 
TXT 265 Suicidal Reports on GLP-1 Drugs: Reuters
09/28/2023
 
 
TXT Physiologic Closed-Loop Control Guidance
09/28/2023
 
 
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
 
 
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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:
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