FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
TXT Lexicon Refiling NDA for Sotagliflozin in Diabetes
03/12/2024
 
 
TXT $500 Million Boost to FDA in President’s Budget Proposal
03/11/2024
 
 
TXT Moderna RSV Vaccine Review Pushed Back
05/10/2024
 
 
TXT Megadyne Removing Mega Soft Electrodes
05/10/2024
 
 
TXT SN Bioscience Gets Fast Track for Lung Cancer
05/10/2024
 
 
TXT Route 92 Medical Recalls Faulty Catheters
05/10/2024
 
 
TXT Breakthrough for Novartis’ Scemblix in Leukemia
05/10/2024
 
 
TXT RAPT Unblinding Data in Trials on Clinical Hold
05/09/2024
 
 
TXT BIO on Collecting Race, Ethnicity Data
05/09/2024
 
 
TXT Device Lawyers Urge SCOTUS to Hear Off-Label Appeal
05/09/2024
 
 
TXT No More Opioid Enriched Enrollment Studies: Califf
05/09/2024
 
 
TXT FDA Defines Device ‘Remanufacturing’
05/09/2024
 
 
TXT FDA Leaders’ Financial Ties to Drug Industry Probed
05/09/2024
 
 
TXT Exocel Bio Selling Unapproved Exosomes: FDA
05/09/2024
 
 
TXT Tandem Diabetes Recalls Pump Mobile App
05/08/2024
 
 
TXT Marks OK with ‘Some’ Gene Accelerated Approval Mistakes
05/08/2024
 
 
TXT Latest Implied Preemption Case Reviewed
05/08/2024
 
 
TXT ORA Reorg’s Impact on Drug Inspections: Cavazzoni
05/08/2024
 
 
TXT FDA on Ongoing Getinge Device Concerns
05/08/2024
 
 
TXT FDA, EPA, USDA Biotechnology Plan
05/08/2024
 
 
TXT FDA Grants, Denies Kaiser 2009 REMS Petition
05/08/2024
 
 
TXT Orphan Status for Mabwell Esophageal Cancer Drug
05/08/2024
 
 
TXT LDT Final Rule Legal Challenges Likely: Attorneys
05/07/2024
 
 
TXT Hearing to Grill FDA Center Directors
05/07/2024
 
 
TXT FDA OKs Breakthrough Colorectal Cancer Test
05/07/2024
 
 
TXT Lilly Gets 6/10 Panel Date for Alzheimer’s BLA
05/07/2024
 
 
TXT House Committee Pressures FDA on China Oversight
05/07/2024
 
 
TXT Bioresearch Monitoring Violations at DBC Research
05/07/2024
 
 
TXT Endo Paying $1.5 Billion Fines, Forfeitures
05/07/2024
 
 
TXT Multiple Violations in Bioptimal Inspection
05/07/2024
 
 
TXT CDRH Product Evaluation/Quality Office Modified
05/07/2024
 
 
TXT FDA OKs TE Code for Paclitaxel Suspension
05/07/2024
 
 
TXT CDER Launches Quantitative Medicine Center
05/06/2024
 
 
TXT J&J Reports Favorable TAR-200 Clinical Data
05/06/2024
 
 
TXT GlycoMimetics Phase 3 Leukemia Study Fails
05/06/2024
 
 
TXT REMS Logic Model Draft Guidance
05/06/2024
 
 
TXT FDA Clears ZygoFix Spinal Fusion Alternative
05/06/2024
 
 
TXT WSJ ‘Apologizes’ for Supporting Califf
05/03/2024
 
 
TXT Dupixent COPD sBLA May Face Review Delay
05/03/2024
 
 
TXT Bill to Restrict Revolving Door When FDAers Depart
05/03/2024
 
 
TXT Inspections Reviewing More Promo Materials: Law Firm
05/03/2024
 
 
TXT Eugia Pharma Gets Fourth FDA-483 in 2024
05/03/2024
 
 
TXT Praise, Suggestions for Informed Consent Guide
05/02/2024
 
 
TXT Decentralized Trials’ Time Has Come: Marks
05/02/2024
 
 
TXT Q-Submission Guide ‘Step in the Wrong Direction’: Expert
05/02/2024
 
 
TXT Office of Translational Sciences Annual Report
05/02/2024
 
 
TXT Mass Spectrometry Guide for Animal Drugs
05/02/2024
 
 
TXT Bill to Ban Tianeptine as a Supplement
05/02/2024
 
 
TXT Thoratec Recalls HeartMate 3 and LVAS Implant Kit
05/02/2024
 
 
TXT Apple Watch Qualified for AFib Trial Monitoring
05/02/2024
 
 
TXT Use Accelerated Approval for Rare Diseases: Commentary
05/01/2024
 
 
TXT Finalize Race, Ethnicity Data Guidance: DFA
05/01/2024
 
 
TXT Multiple Violations at Indonesia’s P.T. Sankei
05/01/2024
 
 
TXT FDA Clears Hybrid Sacroiliac Joint Implant
05/01/2024
 
 
TXT Update Informed Consent Guidance: AdvaMed
05/01/2024
 
 
TXT High-Concentration Humira Biosimilar OK’d
05/01/2024
 
 
TXT NCPA Statement to FDA Compounding Session
05/01/2024
 
 
TXT Listening Session on Advisory Committee Revamp
04/30/2024
 
 
TXT QS Violations in Unapproved Spectrum Devices
04/30/2024
 
 
TXT VITEK 2 Antimicrobial Test Cards Recalled
04/30/2024
 
 
TXT Multiple Pinnacle BioLabs Violations Seen
04/30/2024
 
 
TXT QS, MDR Violations at Future Diagnostics
04/30/2024
 
 
TXT FTC Expands ‘Junk’ Patent Challenges
04/30/2024
 
 
TXT Thiopurine Alert on Intrahepatic Cholestasis of Pregnancy
04/30/2024
 
 
TXT Pfizer Gets Traditional Approval for Tivdak
04/30/2024
 
 
TXT SonarMed Recalls Airway Sensors
04/29/2024
 
 
TXT Panel to Review Novo Nordisk’s Insulin Icodec
04/29/2024
 
 
TXT Human Allogeneic Cell Safety Testing Guide
04/29/2024
 
 
TXT X4 Pharma Gains Xolremdi Approval
04/29/2024
 
 
TXT Guide on Composition and Ingredient Statements
04/29/2024
 
 
TXT Listening Session on Improving Advisory Committees
04/29/2024
 
 
TXT 4-Year Enforcement Discretion for LDTs: Final Rule
04/29/2024
 
 
TXT Human/Animal Materials in Cell/Gene Therapies Guide
04/29/2024
 
 
TXT Marks Outlines CBER 2024 Top Priorities
04/26/2024
 
 
TXT Elekta Recalls Disposable Biopsy Needles
04/26/2024
 
 
TXT Pfizer Hemophilia B Gene Therapy Approved
04/26/2024
 
 
TXT Draft Guide on Drug Composition Statements
04/26/2024
 
 
TXT Roivios Gets Breakthrough Status on Renal Assist
04/26/2024
 
 
TXT Medtronic Spinal Cord Stimulator OK’d
04/26/2024
 
 
TXT InfuTronix Recalls Malfunctioning Infusion Pumps
04/25/2024
 
 
TXT FDA Fast Track for Compass Biliary Tract Cancer Drug
04/25/2024
 
 
TXT Cancer Trial Eligibility Criteria Guidance
04/25/2024
 
 
TXT FDA Tightening ‘Research Use Only’ Tests: Lawyers
04/25/2024
 
 
TXT Fresenius Recalls Stay-Safe Catheter Sets
04/25/2024
 
 
TXT Cancer Trial Performance Status Eligibility Criteria
04/25/2024
 
 
TXT Laboratory Values Cancer Trial Eligibility Criteria
04/25/2024
 
 
TXT Cardinal Health Monoject Inspection Violations
04/25/2024
 
 
TXT Cut Ozempic/Wegovy Price: HELP Committee
04/24/2024
 
 
TXT Curio Postpartum Depression Device Cleared
04/24/2024
 
 
TXT Zydus Lifesciences Issued Another FDA-483
04/24/2024
 
 
TXT Dr. Reddy’s Recalls Sapropterin Dihydrochloride
04/24/2024
 
 
TXT Pivya Approved for Uncomplicated UTIs
04/24/2024
 
 
TXT Priority Review for Jemperli sBLA
04/24/2024
 
 
TXT Boehringer on Improving Informed Consent Guide
04/24/2024
 
 
TXT Biological Promotion Q&A Guidance
04/24/2024
 
 
TXT State Lack of Fenofibrate CV Benefit: Petition
04/24/2024
 
 
TXT Get Involved with FDA on AI/ML: Attorneys
04/23/2024
 
 
TXT 23 No-Longer-Marketed NDAs Withdrawn
04/23/2024
 
 
TXT FDA Launches ‘Home as a Healthcare Hub’
04/23/2024
 
 
TXT New Bladder Cancer Therapy Approved
04/23/2024
 
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>
 
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