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FDA-RELATED NEWS
 
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TXT Replimune Plans RP1 BLA After Positive Trial Data
06/06/2024
 
 
TXT Agency Debars Sievert for 10 Years
06/06/2024
 
 
TXT FDA Reviewers Air Alzheimer’s Drug Issues
06/06/2024
 
 
TXT GAO Cites OTC Hearing Aid Issues
06/06/2024
 
 
TXT Reps Seek Info for ‘Next Generation Cures’
06/06/2024
 
 
TXT Workshop on AI Use in Drug/Biologic Development
06/06/2024
 
 
TXT Pediatric Orthopedic Device Innovation ‘Lags’: Research
06/06/2024
 
 
TXT FDA Places Hold on Biomea Diabetes Trials
06/06/2024
 
 
TXT BIMO Electronic Submission Format Guidance
06/05/2024
 
 
TXT Drug Shortages at Decade High, Last Longer: USP
06/05/2024
 
 
TXT Panel Backs JN.1 Variant-Targeted Covid Vaccine
06/05/2024
 
 
TXT Amgen: Positive Data on Uplizna in Ig G4 Disease
06/05/2024
 
 
TXT FDA Denies Nautilus Glove Reconsideration Request
06/05/2024
 
 
TXT Questions on Alzheimer’s Drug Draft Guidance
06/05/2024
 
 
TXT Medtronic Recalls Malfunctioning StealthStation Software
06/05/2024
 
 
TXT Trexo Robotics Illegally Marketing Devices: FDA
06/05/2024
 
 
TXT Info Collection on Device Recall Authority
06/04/2024
 
 
TXT FDA Promoting ‘Pragmatic Clinical Research’: Califf
06/04/2024
 
 
TXT BMS Reports Positive Opdivo plus Yervoy Data
06/04/2024
 
 
TXT Multiple QS Issues in Techlem Inspection
06/04/2024
 
 
TXT Arrow Recalls FiberOptix Intra-Aortic Catheter
06/04/2024
 
 
TXT 3 Comments on BA/BE Data Integrity Guidance
06/04/2024
 
 
TXT BIMO Processes and Practices Guidance
06/04/2024
 
 
TXT Jiangsu Hengrui Inspection Nets 8-item 483
06/04/2024
 
 
TXT Streamline and Update Biosimilar Development: Council
06/04/2024
 
 
TXT Takeda Moving Narcolepsy Drug to Phase 3
06/03/2024
 
 
TXT FDA Clears Kenota Health IgE Test
06/03/2024
 
 
TXT FDA Debars Punjani Over Imported Generic Viagra
06/03/2024
 
 
TXT Agios Filing NDA on Thalassemia Drug
06/03/2024
 
 
TXT FDA Extends Review of Dupixent in COPD
05/31/2024
 
 
TXT Final Rule Allows Imported Device Destruction
05/31/2024
 
 
TXT Gilead Misses on Trodelvy Confirmatory Study
05/31/2024
 
 
TXT FDA Raises Safety/Efficacy Issues with Lykos PTSD Drug
05/31/2024
 
 
TXT Moderna RSV Vaccine Approved by FDA
05/31/2024
 
 
TXT Scant Evidence for Accelerated Approval Markers: Study
05/30/2024
 
 
TXT Merck sBLA for Keytruda/Chemo in Mesothelioma
05/30/2024
 
 
TXT ‘Defense-Friendly’ 5th Circuit Decision for Hospira
05/30/2024
 
 
TXT FDA Denies Novartis’ Entresto Petition
05/30/2024
 
 
TXT OptumHealth Recalls Nimbus Infusion Pumps
05/30/2024
 
 
TXT Office of Regulatory Affairs, Other Changes Approved
05/30/2024
 
 
TXT Uses of and Issues with AI in Trial Design
05/30/2024
 
 
TXT CDER Lists 10 Pharmaceutical Quality Functions
05/29/2024
 
 
TXT Medline Recalls Endotracheal Tube
05/29/2024
 
 
TXT Disclose ‘Locked’ Hearing Aids: Members of Congress
05/29/2024
 
 
TXT ICH M12 Drug Interaction Guideline Out
05/29/2024
 
 
TXT FDA Oks Amgen’s Bkemv as Soliris Biosimilar
05/29/2024
 
 
TXT Lab Association Sues FDA Over LDT Rule
05/29/2024
 
 
TXT Info Collection on Device De Novo Requests
05/28/2024
 
 
TXT Ostar Beauty Selling Unapproved Medical Devices: FDA
05/28/2024
 
 
TXT Multiple Violations in Lengthy Biomic Inspection
05/28/2024
 
 
TXT Teva Spurns FDA’s Beta-Lactam Drug Recommendation
05/28/2024
 
 
TXT ICH Pharmacoepidemiological Study Guidance Out
05/28/2024
 
 
TXT Sanofi Sarclisa sBLA Accepted for Priority Review
05/28/2024
 
 
TXT Lawmakers Want FDA Jurisdiction on Execution Drugs
05/24/2024
 
 
TXT Respironics Recalls OmniLab Ventilator
05/24/2024
 
 
TXT Panel Backs Shield Colon Cancer Test
05/24/2024
 
 
TXT Hospira Recalls Buprenorphine and Laberalol Lots
05/24/2024
 
 
TXT Vyaire Medical Recall Twin Tube Lines
05/23/2024
 
 
TXT Draft Guide on Vet Drug Residues
05/23/2024
 
 
TXT IDE for Brain Interchange Implant in Stroke Therapy
05/23/2024
 
 
TXT Laurus Labs Cited on GMPs in India
05/23/2024
 
 
TXT FDA Denies Ipsen Somatuline Depot Petition
05/23/2024
 
 
TXT 8 New GDUFA Research Grants in FY 2023: Report
05/23/2024
 
 
TXT FDA Seeks Mandatory Drug Recall, Other Powers
05/23/2024
 
 
TXT PhRMA’s 4 Open FDARA Implementation Issues
05/23/2024
 
 
TXT Comments Extended on Animal Drug Labeling Rule
05/22/2024
 
 
TXT Otsuka Scraps Alzheimer’s Agitation Drug
05/22/2024
 
 
TXT Panel Views Asked on Shield Colorectal Cancer Screen
05/22/2024
 
 
TXT AdvaMed Ideas to ‘Help ASCA Achieve its Promise’
05/22/2024
 
 
TXT Hypoglycemia Risk in Novo’s Weekly Insulin: FDA
05/22/2024
 
 
TXT Harpreet Singh Leaves FDA for Precision Medicine
05/22/2024
 
 
TXT Public Citizen Sues FDA to Force SSRIs Decision
05/22/2024
 
 
TXT Magellan Pays $40 Million Over Faulty Devices
05/22/2024
 
 
TXT PhRMA Supports Post-Approval Safety Guidance
05/22/2024
 
 
TXT CGMP Violations Found in Seatex Inspection
05/21/2024
 
 
TXT Zika No Longer ‘Relevant Disease’: FDA
05/21/2024
 
 
TXT MDMA Suggests Changes to Cybersecurity Guidance
05/21/2024
 
 
TXT Subcutaneous Opdivo User Fee Date Shortened
05/21/2024
 
 
TXT Multiple Violations in Akan Bio's Ayama
05/21/2024
 
 
TXT GSK Reports ‘Positive’ Data from Asthma Trials
05/21/2024
 
 
TXT Hill Moves to Repeal FDA Rule on LDTs
05/21/2024
 
 
TXT Subcutaneous Benlysta Approved for Pediatric Lupus
05/21/2024
 
 
TXT AdvaMed Seeks More Efficient Feedback Requests
05/20/2024
 
 
TXT 2 Interchangeable Eylea Biosimilars Approved
05/20/2024
 
 
TXT FDA Discusses Future of Clinical Research
05/20/2024
 
 
TXT Hold Removed on Friedreich’s Ataxia Therapy
05/20/2024
 
 
TXT EUAs Revoked for 2 Covid Tests
05/17/2024
 
 
TXT Complete Response on Liver Cancer Combo
05/17/2024
 
 
TXT FDA Clears Implicity Heart Failure Algorithm
05/17/2024
 
 
TXT Bipartisan Bill on Clinical Trial Participation
05/17/2024
 
 
TXT Brainomix Gets Clearance for AI e-Lung Tool
05/17/2024
 
 
TXT SCANLY Home Optical Tomography Device Authorized
05/17/2024
 
 
TXT FDA Publishes 32 New Product-Specific Guidances
05/16/2024
 
 
TXT Breakthrough Status for Karius Test
05/16/2024
 
 
TXT Clarify Animal Testing Rules: Humane Society
05/16/2024
 
 
TXT Group Urges $200 Million Boost in FDA Funding
05/16/2024
 
 
TXT FDA Qualifies New Ophthalmic Outcome Tool
05/16/2024
 
 
TXT Lilly Once-Weekly Insulin Meets Trial Endpoints
05/16/2024
 
 
TXT Biogen/Ionis Scrap ALS Drug Development
05/16/2024
 
 
TXT Drug Nanomaterial Guidance Explained
05/16/2024
 
 
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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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