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FDA-RELATED NEWS
 
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TXT Integrating ORA in Centers Has Risks: Analysis
07/26/2023
 
 
TXT Recall Unapproved Phenobarb Products: Sun
07/26/2023
 
 
TXT Central Admixture FDA-483
07/26/2023
 
 
TXT FDA Hits Medical Device ‘Intended Use Creep’
07/26/2023
 
 
TXT Voluntary Consensus Standards Guidance
07/26/2023
 
 
TXT Abbott Recalls Amplatzer Delivery Sheath
07/26/2023
 
 
TXT Defender Pharma NDA for Scopolamine Gel
07/26/2023
 
 
TXT Beckman Coulter Chemistry Analyzer Cleared
07/25/2023
 
 
TXT Stratus Illegally Marketing Biologics: FDA
07/25/2023
 
 
TXT FDA Denies 2 Vanda Tasimelteon Petitions
07/25/2023
 
 
TXT CDRH Adds Device Sterilization Standards
07/25/2023
 
 
TXT FDA Expanding CURE ID
07/25/2023
 
 
TXT 12 Catalent Inspection Observations
07/25/2023
 
 
TXT FDA Told: ‘Generally Accepted’ Often Isn’t
07/25/2023
 
 
TXT Dismissal Sought in FDA-483 Anonymity Suit
07/25/2023
 
 
TXT 3rd Circuit Flunks FDA Again Over Illegal Generics
07/25/2023
 
 
TXT FDA Downplays Impact After Pfizer Tornado
07/24/2023
 
 
TXT ICH Mutagenic Impurities Drug Guidance
07/24/2023
 
 
TXT FDA Spending Bill Will See Veto: White House
07/24/2023
 
 
TXT Horizon Misses on Lupus Phase 2 Endpoint
07/24/2023
 
 
TXT Nesa Medtech Fibroid Mapping App Cleared
07/24/2023
 
 
TXT FDA OKs Verrica NDA for Molluscum Topical
07/24/2023
 
 
TXT ADC Therapeutics Discontinues Phase 2 Trial
07/21/2023
 
 
TXT Bufferin NDA Withdrawn by FDA
07/21/2023
 
 
TXT FDA OKs Emergent’s Anthrax Vaccine
07/21/2023
 
 
TXT Peter Stoll Guilty on Medical Device Felony Count
07/21/2023
 
 
TXT BIO Backs Rare Disease Endpoint Pilot
07/21/2023
 
 
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
 
 
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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