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FDA-RELATED NEWS
 
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TXT FDA Clears BD Alaris Pump Troubles
07/21/2023
 
 
TXT Wuxi Pharmaceutical FDA-483
07/20/2023
 
 
TXT Abiomed Recalls All Lots of 6 Heart Pumps
07/20/2023
 
 
TXT Vir Flu Vaccine Fails Phase 2 Trial
07/20/2023
 
 
TXT Dismiss Norwich Rifaximin Suit: FDA
07/20/2023
 
 
TXT MediView Surgical Augmented Reality Device Cleared
07/20/2023
 
 
TXT Using ctDNA as an Early Endpoint
07/20/2023
 
 
TXT FDA Monitoring Drug Shortages After Pfizer Tornado
07/20/2023
 
 
TXT FDA OKs Vanflyta for Leukemia
07/20/2023
 
 
TXT New FDA Tools in Democrats’ Preparedness Bill
07/19/2023
 
 
TXT Don’t Use Quidel Triage Cardiac Panel: FDA
07/19/2023
 
 
TXT Ex-FDA Gene Therapy Guru Joins Greenleaf
07/19/2023
 
 
TXT 8 Repeat QS Violations at Edge Biologicals
07/19/2023
 
 
TXT Ambrx Gets Fast Track for Prostate Cancer Drug
07/19/2023
 
 
TXT FDA Clears ReddyPort Ventilation Device
07/19/2023
 
 
TXT 4 Observations in SCA Pharmaceuticals FDA-483
07/19/2023
 
 
TXT Keytruda Hits Endpoint in Cervical Cancer Trial
07/19/2023
 
 
TXT FDA Clears Xstrahl Skin Cancer Radiation Therapy
07/19/2023
 
 
TXT FDA Grants Fast Track for Myelofibrosis Drug
07/19/2023
 
 
TXT CGMP Deviations at Centaur Pharmaceuticals
07/18/2023
 
 
TXT Outset Medical Illegally Marketing Tablo System: FDA
07/18/2023
 
 
TXT FDA Boosts Translational Sciences ‘Achievements’
07/18/2023
 
 
TXT Legislators Hit FDA's India, China Inspections
07/18/2023
 
 
TXT Akebia Resubmitting Kidney Disease NDA
07/18/2023
 
 
TXT Medtronic Recalls Faulty Defibrillators
07/18/2023
 
 
TXT Suggestions for Pediatric Drug Guidance
07/18/2023
 
 
TXT GAO Regenerative Medicine Policy Options
07/18/2023
 
 
TXT Catalent Indiana Facility Cited in Form-483
07/17/2023
 
 
TXT Quidel Cardio Recalls Cardiac Panel Test
07/17/2023
 
 
TXT Guide Updated on Device Development Tools
07/17/2023
 
 
TXT Ex-FDA Chief Counsel Joins Berkley Research
07/17/2023
 
 
TXT AstraZeneca RSV Drug Beyfortus Approved
07/17/2023
 
 
TXT FDA Warns About Using RoyalVibe Ultrasounds
07/17/2023
 
 
TXT Fresenius Kabi Facility Hit With FDA-483
07/14/2023
 
 
TXT MedRhythms Stroke Neurorehabilitation System Cleared
07/14/2023
 
 
TXT EarliTec Autism Second Gen Device Cleared
07/14/2023
 
 
TXT Bill Introduced on Biosimilar Substitutions
07/14/2023
 
 
TXT Guide on Postmarketing Study Noncompliance
07/14/2023
 
 
TXT Veklury Approved for Covid Plus Renal Impairment
07/14/2023
 
 
TXT FDA Guide on Postmarketing Noncompliance Good Cause
07/13/2023
 
 
TXT Oncology Drug Pilot on LDT Performance Criteria
07/13/2023
 
 
TXT Zyto Illegally Marketing Galvanic Skin Device: FDA
07/13/2023
 
 
TXT FDA Hernia Repair Surgical Mesh Info
07/13/2023
 
 
TXT Draeger Recalls Ventilator Over Battery Issues
07/13/2023
 
 
TXT Cell, Gene Manufacturing Changes, Comparability
07/13/2023
 
 
TXT Opill Approved as 1st OTC Oral Contraceptive
07/13/2023
 
 
TXT CGMP, Other Issues at NeilMed Pharmaceuticals
07/12/2023
 
 
TXT Disclose Drug, Supplement Animal Ingredients: Petition
07/12/2023
 
 
TXT Boston Scientific Brain Stimulation Software OK’d
07/12/2023
 
 
TXT FDA Warns 2 Firms on Human Cells/Tissues
07/12/2023
 
 
TXT Most Common 2022 BIMO Violations
07/12/2023
 
 
TXT FDA Wants More PSA Applicants
07/12/2023
 
 
TXT Lymphoma Trial Enrollment Paused After 7 Deaths
07/11/2023
 
 
TXT Praise for FDA Final PFDD Guidance
07/11/2023
 
 
TXT Innovative Manufacturing Workshop Positive Comments
07/11/2023
 
 
TXT No Higher Death Risk in Paclitaxel-Coated Devices: FDA
07/11/2023
 
 
TXT Metabolism Inborn Errors Guidance
07/11/2023
 
 
TXT More Study of Patient-Reported Frailty Needed: FDA
07/11/2023
 
 
TXT SCOTUS Should Hear Label Highlights Appeal: PhRMA
07/11/2023
 
 
TXT FDA Enforcement Discretion Policy for Pandemic Tests
07/11/2023
 
 
TXT Takeda Withdraws BLA for Dengue Vaccine
07/11/2023
 
 
TXT FDA Clears Avatar VR Surgical Planner
07/10/2023
 
 
TXT Cipla Recalls 6 Albuterol Sulfate Aerosol Batches
07/10/2023
 
 
TXT DTC Guidance May Signal Enforcement Shift: Attorneys
07/10/2023
 
 
TXT Illumina Cybersecurity Vulnerability is Class 2: FDA
07/10/2023
 
 
TXT Ipsen Planning FDA Elifibranor Application
07/10/2023
 
 
TXT FDA Full Approval for Eisai’s Leqembi
07/10/2023
 
 
TXT CRL for Regeneron Aflibercept BLA
07/10/2023
 
 
TXT FDA to Again Try to Regulate LDTs: Attorneys
07/10/2023
 
 
TXT FDA OKs SystImmune Phase 1 Lung Cancer Study
07/10/2023
 
 
TXT FDA Actions Follow Advisors 88% of Time: Analysis
07/10/2023
 
 
TXT 8 Observations on Ipca Labs FDA-483
07/10/2023
 
 
TXT CRL for Amneal Parkinson’s Drug
07/10/2023
 
 
TXT CDER Site-Selection Model MAPP
07/10/2023
 
 
TXT CDRH Moving to Electronic Export Docs
07/10/2023
 
 
TXT 29-Page Intas FDA-483
07/10/2023
 
 
TXT Outset Medical Gets Tablo Warning Letter
07/10/2023
 
 
TXT Hemogenyx CAR-T Therapy on Clinical Hold
07/10/2023
 
 
TXT VCN-01 Orphan Status for Pancreatic Cancer
06/30/2023
 
 
TXT Teleflex Recalls Endotracheal Tubes
06/30/2023
 
 
TXT House Bill on Provisional Drug Approvals
06/30/2023
 
 
TXT More Regulation Needed for Generics: Bloomberg
06/30/2023
 
 
TXT 8 Information Collections Approved by OMB
06/30/2023
 
 
TXT FDA Allows 1st Master File Use for Sterilizer
06/30/2023
 
 
TXT FDA WEBVIEW CLOSED JULY 4TH WEEK
06/30/2023
 
 
TXT Rhinosinusitis Drug Development Guidance
06/29/2023
 
 
TXT Compounding Inspection, Oversight FAQs
06/29/2023
 
 
TXT FDA OKs 1st Diabetes Cellular Therapy
06/29/2023
 
 
TXT Info Collection on Advisory Committee Regs
06/29/2023
 
 
TXT 18-Page FDA-483 on Ipca Laboratories Inspection
06/29/2023
 
 
TXT BioMarin Gene Therapy for Hemophilia A OK’d
06/29/2023
 
 
TXT Alvotech Complete Response Due to Inspection
06/29/2023
 
 
TXT 2 Roche Assays Cleared for Alzheimer’s
06/29/2023
 
 
TXT Prioritize Cancer Trial Diversity: Researchers
06/29/2023
 
 
TXT Orthopedic Implant Guide Guidance
06/28/2023
 
 
TXT Oncology Drug Approval Trends
06/28/2023
 
 
TXT CBER Updates 2023 Guidance Agenda
06/28/2023
 
 
TXT 3 GOP Senators Push FDA on Chinese Cancer Drugs
06/28/2023
 
 
TXT Comments on OPDP Quantitative Claims Research
06/28/2023
 
 
TXT FDA Reiterates NuVasive Device Indications
06/28/2023
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving