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FDA-RELATED NEWS
 
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TXT Satsuma Plans Migraine NDA After Data Miss
11/14/2022
 
 
TXT Luer-Activated Valve Connector FDA Alert
11/23/2022
 
 
TXT Janssen Says Spravato Tops Seroquel in Trial
11/23/2022
 
 
TXT EUA for Lucira Covid-19 and Flu Test
11/23/2022
 
 
TXT FDA Waives Panel Meeting on Biomarin Gene Therapy
11/23/2022
 
 
TXT New Hemophilia B Gene Therapy Approved
11/22/2022
 
 
TXT Controversy Seen in CDS Software Final Guidance
11/22/2022
 
 
TXT Alert on Prolia and Severe Hypocalcemia
11/22/2022
 
 
TXT FDA Modeling, Simulation Successes
11/22/2022
 
 
TXT GSK Pulls Blenrep Accelerated Approval at FDA’s Request
11/22/2022
 
 
TXT Multiple Violations at Invitrx Therapeutics
11/22/2022
 
 
TXT Latest Philips Respironics MDRs
11/22/2022
 
 
TXT Webinar on Rx Drug Labeling Resources
11/21/2022
 
 
TXT FDA Updates Web Page on Medtronic HeartWare Recalls
11/21/2022
 
 
TXT Zimmer Biomet New Persoa Tibis Cleared
11/21/2022
 
 
TXT FDA OKs Jazz sBLA for Mon./Wed./Fri. Rylaze Dosing
11/21/2022
 
 
TXT Gamida Cell BLA Review Extended by 3 Months
11/21/2022
 
 
TXT Provention Bio Diabetes Delayer Approved
11/18/2022
 
 
TXT Inspections Focusing on Management Responsibility: FDA
11/18/2022
 
 
TXT Pfizer/BioNTech on ‘Encouraging’ Covid Booster Data
11/18/2022
 
 
TXT Iovance Pushes Back BLA for Melanoma Therapy
11/18/2022
 
 
TXT Bernie Sanders to Head HELP Committee
11/18/2022
 
 
TXT Philips Respironics Reports More Problems with Ventilators
11/18/2022
 
 
TXT FDA Cybersecurity Modernization Action Plan
11/17/2022
 
 
TXT Comments Sought on Proposed NDC Revision
11/17/2022
 
 
TXT FDA Warns 7 Supplement Companies About CV Claims
11/17/2022
 
 
TXT FDA Approves Lilly Interchangeable Insulin Product
11/17/2022
 
 
TXT 9 Senators Want FDA Medication Abortion Action
11/17/2022
 
 
TXT Advisors Back Ardelyx’ Kidney Disease Drug
11/17/2022
 
 
TXT Pazdur Puts Foot Down on Single Country Trials
11/17/2022
 
 
TXT FDA Planning White Oak Return Under Hybrid Approach
11/17/2022
 
 
TXT Class 1 Recall on Omnipod Insulin Delivery System
11/17/2022
 
 
TXT FDA Denies 2 Covid-19 Vaccine Petitions
11/16/2022
 
 
TXT Takeaways from Clinical Trial Enforcement Panel
11/16/2022
 
 
TXT NEST Unique Device Identifier Playbook
11/16/2022
 
 
TXT Pass PASTEUR Act Before Congress Ends: 165 Groups
11/16/2022
 
 
TXT FDA Preliminary Assessment on OTC Naloxone
11/16/2022
 
 
TXT ‘Put Aduhelm Approval on Hold’: Researchers
11/16/2022
 
 
TXT CA Appeals Court Upholds Federal Preemption
11/16/2022
 
 
TXT FDA Updates Cybersecurity Playbook
11/15/2022
 
 
TXT Certain Naloxone Products Could be OTC: FDA
11/15/2022
 
 
TXT FDA Questions Ardelyx’ Tenapanor
11/15/2022
 
 
TXT Workshop on Using Consensus Standards in Device Submissions
11/15/2022
 
 
TXT 1 Observation on Athenex Pharma FDA-483
11/15/2022
 
 
TXT Comments on Computer Software Assurance Guidance
11/15/2022
 
 
TXT Warning Letter ‘Top 10’ GMP Deficiencies
11/15/2022
 
 
TXT ImmunoGen’s Elahere OK’d for Several Cancers
11/14/2022
 
 
TXT Insulet Device Correction on ‘Melting’ Omnipod 5
11/14/2022
 
 
TXT Protalix, Chiesi Resubmit Fabry Disease BLA
11/14/2022
 
 
TXT Roche Alzheimer’s Drug Misses in 2 Phase 3 Studies
11/14/2022
 
 
TXT FDA Clears Surgical Augmented Reality Software
11/14/2022
 
 
TXT Regulatory Review Period for Merck’s Prevymis
11/11/2022
 
 
TXT GSK Narrows Zejula Indication at FDA’s Request
11/11/2022
 
 
TXT FTC Takes Issue with Jazz Orange Book Listing
11/11/2022
 
 
TXT Imfinzi/Imjudo OK’d for Lung Cancer
11/11/2022
 
 
TXT ‘Device’ Definition Guidance
11/10/2022
 
 
TXT ICH Guide on Cell-line Product Viral Safety
11/10/2022
 
 
TXT Expedited Program Quality Assessment MAPP
11/10/2022
 
 
TXT Change Ethical Issues for Kids’ Products: AdvaMed
11/10/2022
 
 
TXT 2 Comments on Computer Software Assurance Guidance
11/10/2022
 
 
TXT FDA Refuses to File NurOwn BLA
11/10/2022
 
 
TXT Strengthen AI Product Approval: Researchers
11/10/2022
 
 
TXT Insulet Diabetes Manager Correction
11/09/2022
 
 
TXT Panel Backs AstraZeneca Asthma Product in Adults
11/09/2022
 
 
TXT ZoomRx Keys to Better Oncology Promo Messaging
11/09/2022
 
 
TXT 18 Observations on Lupin FDA-483
11/09/2022
 
 
TXT ImprimisRx NJ FDA-483 Has 9 Observations
11/09/2022
 
 
TXT Reject FDA Privilege Claim in FOIA Case: WLF
11/09/2022
 
 
TXT RapidAI’s Lastest Version of Rapid ICH Cleared
11/09/2022
 
 
TXT NatureLab Adulterated and Misbranded Dietary Supplements
11/08/2022
 
 
TXT CGMP Violations at Abraxis Bioscience
11/08/2022
 
 
TXT ANDA Sameness Evaluation Guidance
11/08/2022
 
 
TXT FDA Raises Sabizabulin ‘Uncertainties’
11/08/2022
 
 
TXT Omeros Loses Appeal on Stem Cell Transplant Drug
11/08/2022
 
 
TXT Drug-Device Combo Firms Quiz FDA on Specs
11/08/2022
 
 
TXT Start Device Covid Transition Plans Now: Attorneys
11/08/2022
 
 
TXT FDA Seeks New Accelerated Approval Requirement
11/08/2022
 
 
TXT 7 Combination Product Guidances on the Way
11/08/2022
 
 
TXT Guide on Early Studies on Cell/Gene Therapies
11/07/2022
 
 
TXT Guide on Bioanalytical Method Validation
11/07/2022
 
 
TXT GSK Blenrep Phase 3 Misses Primary Endpoint
11/07/2022
 
 
TXT FDA Places Hold on Verve Hypercholesterolemia Drug
11/07/2022
 
 
TXT Verrica Pharma Refiling NDA for VP-102
11/07/2022
 
 
TXT Device Postmarket Surveillance Info Collection
11/07/2022
 
 
TXT BioMarin Asked to Submit New Data on Gene Therapy
11/07/2022
 
 
TXT Guide on Bioanalytical Method Validation
11/04/2022
 
 
TXT Guide on Studying Multiple Cell/Gene Therapies
11/04/2022
 
 
TXT Apellis Pharma NDA Review Extended on New Data
11/04/2022
 
 
TXT New MDIC Framework on Device Trials
11/04/2022
 
 
TXT 21 State AGs Urge FDA OK of OTC Birth Control
11/04/2022
 
 
TXT GSK Stops UTI Trials and Opts for NDA
11/03/2022
 
 
TXT FDA, Others Launch Global Substances System
11/03/2022
 
 
TXT Califf Touts Progress in Drug Compounding Oversight
11/03/2022
 
 
TXT Updated Meeting Definitions
11/03/2022
 
 
TXT Guidance on Oncology Cross-Labeling
11/03/2022
 
 
TXT Lifting Barriers to Transgender People in Cancer Trials
11/03/2022
 
 
TXT Safety Alert on Infant Head Shaping Pillows
11/03/2022
 
 
TXT Panel OKs CDER Quality Management Maturity Program
11/03/2022
 
 
TXT Guidance on Pharmaceutical Carcinogenicity Testing
11/02/2022
 
 
TXT Oncology Drug Cross Labeling Guidance
11/02/2022
 
 
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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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