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FDA-RELATED NEWS
 
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TXT Lilly’s Donanemab Tops Aduhelm in Study
12/01/2022
 
 
TXT Act on Orphan Drug Exclusivity: Attorney
12/01/2022
 
 
TXT Medical Device Recalls at Two-Year High: Sedgwick
12/01/2022
 
 
TXT Make UDI Publicly Available in Databases: Petition
12/01/2022
 
 
TXT FDA Grants, Denies Parts of Microbiome Petition
11/30/2022
 
 
TXT 2 Admit Role in $38 Million Compounding Fraud
11/30/2022
 
 
TXT Congress Should Pass VALID Act on LDTs: Advocates
11/30/2022
 
 
TXT Janssen Sues Amgen Over Stelara Biosimilar Plans
11/30/2022
 
 
TXT Merck in Keytruda Patent Dispute with Johns Hopkins
11/30/2022
 
 
TXT Lilly’s Bebtelovimab Not Authorized in U.S.
11/30/2022
 
 
TXT Eisai/Biogen Report ‘Promising’ Alzheimer’s Data
11/30/2022
 
 
TXT Ex-BD Official Seeks DoJ Referral Against Company
11/29/2022
 
 
TXT ‘Objectionable Conditions’ at Arbor Eyecare
11/29/2022
 
 
TXT CDER Hearing Delay on NDA is ‘Unfounded’: Lexicon
11/29/2022
 
 
TXT Suggestions to Improve OTC Drug Draft Reg
11/29/2022
 
 
TXT Roche Withdraws Tecentriq Bladder Cancer Indication
11/29/2022
 
 
TXT ‘Skinny Labels’ Lead to Earlier Competition: Study
11/29/2022
 
 
TXT Supplement Reform Appears Dead for 2022: Report
11/29/2022
 
 
TXT Caribou Bio Wins 2 Designations from FDA
11/29/2022
 
 
TXT FDA Rejects Spectrum's Lung Cancer Drug
11/28/2022
 
 
TXT Sarepta BLA for Duchenne Muscular Dystrophy
11/28/2022
 
 
TXT NeuroLogica BodyTom CT Scanner Cleared by FDA
11/28/2022
 
 
TXT Enforcement Guide on Fecal Microbiota for Transplantation
11/28/2022
 
 
TXT No REMS Needed for Gene Therapy: FDA
11/28/2022
 
 
TXT Device Color Additive Risk Calculator Qualified
11/28/2022
 
 
TXT 2nd Alzheimer’s Therapy Death Raises Questions: Journal
11/28/2022
 
 
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 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 New Hemophilia B Gene Therapy Approved
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 Protalix, Chiesi Resubmit Fabry Disease BLA
11/14/2022
 
 
TXT Roche Alzheimer’s Drug Misses in 2 Phase 3 Studies
11/14/2022
 
 
TXT Satsuma Plans Migraine NDA After Data Miss
11/14/2022
 
 
TXT ImmunoGen’s Elahere OK’d for Several Cancers
11/14/2022
 
 
TXT Insulet Device Correction on ‘Melting’ Omnipod 5
11/14/2022
 
 
TXT 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 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 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 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
 
 
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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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