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FDA-RELATED NEWS
 
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TXT FDA Withdraws 8 No-Longer-Marketed ANDAs
06/01/2023
 
 
TXT FDA OKs Pfizer Abrysvo RSV Vaccine
06/01/2023
 
 
TXT Migraine Drug Development Guidance
06/01/2023
 
 
TXT AstraZeneca Ends Brazikumab Development
06/01/2023
 
 
TXT Balance AI Optimism and Pessimism: Califf
06/01/2023
 
 
TXT Roche/Genentech Suggestions for nAMD Guidance
06/01/2023
 
 
TXT Patient Access to At-Home Technologies
06/01/2023
 
 
TXT Doc Bought Oncology Meds to Sell for Profit: DoJ
06/01/2023
 
 
TXT FDA Clears Ezra Flash AI for MRI Quality
06/01/2023
 
 
TXT CDER Drug Policy Guru Heads to Morgan Lewis
06/01/2023
 
 
TXT Clinical Hold on PepGen IND Application
05/31/2023
 
 
TXT Precision BioSciences to Meet with FDA on Azer-Cel
05/31/2023
 
 
TXT Groups Want Regulation of Lab-Developed Tests
05/31/2023
 
 
TXT Junshi Bio Inspection to Advance Toripalimab BLA
05/31/2023
 
 
TXT FDA to Permit In-Person End-of-Phase 2 Meetings
05/31/2023
 
 
TXT FDA Alert on Compounded Semaglutide
05/31/2023
 
 
TXT CDER Risk, Safety Report for 2022 Issued
05/31/2023
 
 
TXT FDA Limited in Managing Drug Shortages: Pazdur
05/31/2023
 
 
TXT FDA Proposes 1-Page Patient Medication Information
05/30/2023
 
 
TXT Violations at Advanced Compounding Solutions
05/30/2023
 
 
TXT Priority Review for BMS Lung Cancer Drug
05/30/2023
 
 
TXT Concerns with Macular Degeneration Guidance
05/30/2023
 
 
TXT Janssen NDA for Pulmonary Hypertension Drug
05/30/2023
 
 
TXT Think Surgical Gains Clearance for TMINI Robot
05/30/2023
 
 
TXT Pfizer’s Marstacimab Meets Phase 3 Goals
05/30/2023
 
 
TXT Akebia Therapeutics Resubmitting Anemia NDA
05/30/2023
 
 
TXT Suggestions for Oncology Accelerated Approval Guidance
05/30/2023
 
 
TXT iRhythm Gets Warning Letter on Heart Monitor
05/30/2023
 
 
TXT BMS Breyanzi ‘Deep and Durable Efficacy’
05/26/2023
 
 
TXT Progression-Free Survival Improves in DUO-E Trial: AZ
05/26/2023
 
 
TXT 3 Observations in UCB Pharma FDA-483
05/26/2023
 
 
TXT Updated Boxed Warning for Rx Stimulants
05/26/2023
 
 
TXT Comments on Gene, Cell Therapy Surveillance
05/26/2023
 
 
TXT Colorectal Cancer NDA Gets Priority Review
05/26/2023
 
 
TXT Neuralink Says FDA OKs Brain Implant Trial
05/26/2023
 
 
TXT Sitravatinib Fails in Phase 3 Lung Cancer Study
05/25/2023
 
 
TXT Power Morcellation Tissue Containment Guidance
05/25/2023
 
 
TXT Trial Covariate Adjustment Guidance
05/25/2023
 
 
TXT Drug, Medical Device Recalls Up in 1st Quarter
05/25/2023
 
 
TXT Act on Cancer Chemo Shortages: Michigan Reps
05/25/2023
 
 
TXT Pfizer Paxlovid NDA Approved for Covid
05/25/2023
 
 
TXT Regenerelle Marketing Unapproved HCT/P Products: FDA
05/25/2023
 
 
TXT Integra Recalls Products Over Endotoxin Testing
05/25/2023
 
 
TXT Phathom Resubmits Vonoprazan NDA
05/24/2023
 
 
TXT Generally Accepted Scientific Knowledge Guidance
05/24/2023
 
 
TXT FDA Extends Review of Sarepta Gene Therapy
05/24/2023
 
 
TXT Tox Study Whole Slide Imaging Guidance
05/24/2023
 
 
TXT FDA Wants Comments on REMS Vendor Changes
05/24/2023
 
 
TXT ICH Good Clinical Practice Guide Comments
05/24/2023
 
 
TXT FDA Seeks Contractors for Drug Performance Automation
05/24/2023
 
 
TXT FDA Warns India Pharmacy Over Unapproved Drugs
05/24/2023
 
 
TXT SD Biosensor Recalls Contaminated Covid Tests
05/24/2023
 
 
TXT Call Out Lawyer Client-Seeking Ads: Petition
05/24/2023
 
 
TXT Ex-FDAer Schiller on Accelerated Approval Guide
05/23/2023
 
 
TXT Melanoma Imaging Device Get Breakthrough Status
05/23/2023
 
 
TXT Lawyer’s Motion to Remain Anonymous Granted
05/23/2023
 
 
TXT FDA OK’s New Opioid Use Disorder Option
05/23/2023
 
 
TXT Abbott Touts Data on Dual Chamber Pacemaker
05/23/2023
 
 
TXT FDA Approval Reciprocity Bill Reintroduced
05/23/2023
 
 
TXT FDA Denies Petition for PPI Pneumonia Warning
05/23/2023
 
 
TXT Contract Testing Lab Gets Warning Letter
05/23/2023
 
 
TXT New FDA MOU for Distributed Manufacturing
05/23/2023
 
 
TXT Figures in Tellus Clinical Trial Fraud Case Acquitted
05/23/2023
 
 
TXT Petition for Warning on Diabetes Drugs Denied
05/22/2023
 
 
TXT CDRH Portal Expanded to Pre-Submission Feedback
05/22/2023
 
 
TXT Novo Nordisk Plans NDA for Oral Obesity Drug
05/22/2023
 
 
TXT Rain Oncology Scraps Milademetan
05/22/2023
 
 
TXT FDA OKs Opiant Pharma’s Opioid Overdose Spray
05/22/2023
 
 
TXT FDA Issues 483 to Aurobindo API Facility
05/19/2023
 
 
TXT DTC Research Supports Disclosures on Endpoint Differentiation
05/19/2023
 
 
TXT Abiomed Recalls Impella 5.5. Blood Pump
05/19/2023
 
 
TXT Zoll Settles Case Against China-made ECG Cables
05/19/2023
 
 
TXT Topical Gene Therapy for Wounds Approved
05/19/2023
 
 
TXT ‘Bionic Pancreas’ Cleared by FDA
05/19/2023
 
 
TXT Revoke Approval for MSN’s Generic Hetlioz: Vanda
05/18/2023
 
 
TXT Nephron Pharmaceuticals Warehouse FDA-483
05/18/2023
 
 
TXT AbbVie Gets Rinvoq OK for Crohn’s
05/18/2023
 
 
TXT Draeger Recalls Seattle CPAP Device and Components
05/18/2023
 
 
TXT Child Cancer Research Bill Reintroduced
05/18/2023
 
 
TXT House Dems Working on Cancer Drug Shortage
05/18/2023
 
 
TXT Appropriators Cut FDA Budget by $600 million
05/18/2023
 
 
TXT Panel Backs Pfizer’s RSV Vaccine
05/18/2023
 
 
TXT 2 Pediatric Drug Approval Guidances
05/17/2023
 
 
TXT ICU Medical Recalls Pumps Over Battery Defect
05/17/2023
 
 
TXT Device Panel to Tackle Health Equity
05/17/2023
 
 
TXT Reviewers Question Intercept’s Liver Drug
05/17/2023
 
 
TXT Bill to Use Industry Penalties for Cancer Research
05/17/2023
 
 
TXT Califf Hopeful on Alzheimer’s, Obesity Drug Data
05/17/2023
 
 
TXT Drug Company Patent Violations Cost $40 Billion: Study
05/17/2023
 
 
TXT Reject Apotex Generic Fintepla ANDA: UCB
05/17/2023
 
 
TXT Prothena Adds Ex-FDA Neuroscience Head to Board
05/17/2023
 
 
TXT Attorney Sues FDA to Keep Name Off FDA-483
05/17/2023
 
 
TXT Pharmedica CGMP Violations Result in Plant Shutdown
05/16/2023
 
 
TXT Ipca Laboratories FDA-483
05/16/2023
 
 
TXT FDA Issues with Sea-Long Medical Treatment Hoods
05/16/2023
 
 
TXT Bespoke Gene Therapy Portfolio has 8 Diseases
05/16/2023
 
 
TXT Let Compounders Help with Drug Shortages: Op-Ed
05/16/2023
 
 
TXT Did Recarbrio Approval Break FDA Rules?
05/16/2023
 
 
TXT Judge Hits Precision Lens with $487 Million Fine
05/16/2023
 
 
TXT Abbott Spinal Stimulation Devices OK for Back Pain
05/16/2023
 
 
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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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  • Major news insights, follow-ups and reactions in each product area;
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  • Related industry news capsules;
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