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FDA-RELATED NEWS
 
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TXT Universal Meditech Recalls All Test Products
09/01/2023
 
 
TXT Hugel Refiles BLA Addressing FDA Concerns
09/01/2023
 
 
TXT Sage Reorganizing to Support Zurzuave Launch
08/31/2023
 
 
TXT BD Suggestions for Microbiology Panel
08/31/2023
 
 
TXT Guide on Real-World Data/Evidence
08/31/2023
 
 
TXT AdvaMed on At-Home Medical Technology Use
08/31/2023
 
 
TXT Fight Bone Graft Infections: Michigan Lawmakers
08/31/2023
 
 
TXT Keep FDA Logo Out of Materials: Agency
08/31/2023
 
 
TXT FDA Quality Management White Paper
08/31/2023
 
 
TXT Opioid Crisis Worse Despite Progress: Califf
08/31/2023
 
 
TXT Real-World Evidence Regulatory Guidance
08/30/2023
 
 
TXT FibroGen Duchenne Study Misses Endpoint
08/30/2023
 
 
TXT Hamilton Medical Recalls Ventilators
08/30/2023
 
 
TXT Drug Distribution Security Guidance
08/30/2023
 
 
TXT Drug Tracing ‘Stabilization Period’
08/30/2023
 
 
TXT Comments on Increasing Home Medical Tech Use
08/30/2023
 
 
TXT FDA Renews 5-Year M-CERSI Agreement
08/30/2023
 
 
TXT Breakthrough Designation for Quest Diagnostic
08/30/2023
 
 
TXT RAISE Program Explained
08/30/2023
 
 
TXT CGMP Violations at K.C. Pharmaceuticals
08/29/2023
 
 
TXT Gadal Laboratories CGMP Violations
08/29/2023
 
 
TXT Tesla BioHealing Illegally Marketing Devices
08/29/2023
 
 
TXT FDA Monitoring Social Media Drug Promotion: Post
08/29/2023
 
 
TXT 9 GA Congress Members Want Chemo Transparency
08/29/2023
 
 
TXT FDA Promotes Dose Optimization Innovation: Report
08/29/2023
 
 
TXT Texas Approves Drug Import Plan
08/29/2023
 
 
TXT Lawmakers Ask FDA to Fix Orange Book Loopholes
08/29/2023
 
 
TXT ICU Medical Infusion Pump Cleared
08/29/2023
 
 
TXT Janssen Files sBLA for Expanded Rybrevant
08/28/2023
 
 
TXT Data Integrity Issues at Synapse Labs: Petition
08/28/2023
 
 
TXT FDA Clears BioProtect Balloon Implant
08/28/2023
 
 
TXT AbbVie sBLA for Skyrizi in Crohn’s
08/28/2023
 
 
TXT Novocure Phase 3 Study Misses Primary Endpoint
08/28/2023
 
 
TXT Merck, Eisai Stop LEAP-010 Trial
08/25/2023
 
 
TXT Enforcement Deferred on Drug Security Needs
08/25/2023
 
 
TXT Comments Sought on Pepaxto’s Proposed Withdrawal
08/25/2023
 
 
TXT CDRH Qualifies Tool on Material Biostability
08/25/2023
 
 
TXT FDA OKs New Veklury Covid Indication
08/24/2023
 
 
TXT Akebia Plans 3rd Quarter Vadadustat NDA Resubmission
08/24/2023
 
 
TXT Fast Track for Abdominal Aneurysm Product
08/24/2023
 
 
TXT Paragonix Donor Lung Preservation Device Cleared
08/24/2023
 
 
TXT More Drug Approval Transparency Needed: Studies
08/24/2023
 
 
TXT FDA Approves 1st Tysabri Biosimilar
08/24/2023
 
 
TXT Finalized Informed Consent Guidance Analyzed
08/24/2023
 
 
TXT FDA Panel to Review Diabetes NDA Dispute
08/23/2023
 
 
TXT Regulate Cannabis Under Existing Law: CFCR
08/23/2023
 
 
TXT Dingell Concerned About TB from Bone Grafts
08/23/2023
 
 
TXT Changes Sought in FDA Diabetes Endpoint Guidance
08/23/2023
 
 
TXT Lilly’s Retevmo Hits Phase 3 Trial PFS Endpoint
08/23/2023
 
 
TXT ‘Objectionable Conditions’ in Clinical Investigation
08/23/2023
 
 
TXT OTC Devices ‘Don’t Need Patient Self-Diagnosis’: CHPA
08/22/2023
 
 
TXT FDA Warns Walmart, Amazon on Molluscum Drugs
08/22/2023
 
 
TXT Ambu Illegally Selling Airway Device: FDA
08/22/2023
 
 
TXT Clinical Hold Lifted on Sickle Cell Drug
08/22/2023
 
 
TXT Require Generic Ozobax Safety Data: Metacel
08/22/2023
 
 
TXT FDA Reorg Could Hurt Supplements: Duncan
08/22/2023
 
 
TXT Drug Shortages are National Security Risk: Califf
08/22/2023
 
 
TXT OPDP Cites Exeltis’ Promos on Social Media
08/21/2023
 
 
TXT Device Cybersecurity Guide Coming by 9/30: FDA
08/21/2023
 
 
TXT Eylea OK’d After Fixing Inspection Findings
08/21/2023
 
 
TXT FDA Partial Hold on Gilead’s Magrolimab
08/21/2023
 
 
TXT NDA for Myelodysplastic Syndromes Anemia
08/21/2023
 
 
TXT Drug Firms’ $300 Million Fine Over Price-Fixing
08/21/2023
 
 
TXT Califf to Put Pressure on Indian Drug Makers
08/18/2023
 
 
TXT Anika Gains Rotator Cuff Implant Clearance
08/18/2023
 
 
TXT Veopoz OK’d and Eylea Issues Fixed: Regeneron
08/18/2023
 
 
TXT Merck Touts Welireg in Kidney Cancer
08/18/2023
 
 
TXT FDA Oks Ipsen’s Sohonos for FOP
08/17/2023
 
 
TXT Cardiosave Balloon Pump Recall Class 1: FDA
08/17/2023
 
 
TXT BlueWind De Novo for Incontinence Device
08/17/2023
 
 
TXT Vanda Pushes Back on Hetlioz sNDA Hearing Denial
08/17/2023
 
 
TXT Medical Device, Drug Recalls Drop in Q2: Sedgwick
08/17/2023
 
 
TXT Orphan Status for Biliary Tract Cancer Drug
08/17/2023
 
 
TXT Priority Review for Servier’s Tibsovo sNDA
08/16/2023
 
 
TXT Abortion Drug Can Remain on Market: Appeals Court
08/16/2023
 
 
TXT FDA’s Lighter Enforcement May be Ending: Attorney
08/16/2023
 
 
TXT New FDA PathologAI Initiative
08/16/2023
 
 
TXT Deficiencies in CM and RTRT-D NDA Submissions
08/16/2023
 
 
TXT Multiple Denison Pharmaceuticals Violations
08/16/2023
 
 
TXT CDRH Prefers Guidance Comments in Table Format
08/16/2023
 
 
TXT AstraZeneca Gets 1st OPDP 2023 Warning Letter
08/15/2023
 
 
TXT Informed Consent Guidance
08/15/2023
 
 
TXT QS Violations at TEI Biosciences
08/15/2023
 
 
TXT Hold Lifted on Arcellx Myeloma Drug
08/15/2023
 
 
TXT Info Collection Revision on BLA Procedures
08/15/2023
 
 
TXT FDA Denies St. Jude Codeine Use Petition
08/15/2023
 
 
TXT More Supplements Risk Oversight Coming: Califf
08/15/2023
 
 
TXT Breakthrough Status for AngioVac System
08/15/2023
 
 
TXT Florida Amends FOIA Lawsuit Against FDA
08/14/2023
 
 
TXT Clinical Hold on AML Cell Therapy
08/14/2023
 
 
TXT FDA Extends Review of Chikungunya Vaccine
08/14/2023
 
 
TXT Phillips Recalls Trilogy EVO Ventilators
08/14/2023
 
 
TXT Biocon Malaysia Plant Hit with 8-item 483
08/14/2023
 
 
TXT Guide on Off-the-Shelf Software in Devices
08/11/2023
 
 
TXT Astellas sNDA Filed for Pediatric Cresemba
08/11/2023
 
 
TXT Ceribell’s ClarityPro For Detecting Seizures
08/11/2023
 
 
TXT FDA Warning on 15 Universal Meditech Tests
08/11/2023
 
 
TXT FDA On Parametric Release for Sterile Drugs
08/11/2023
 
 
TXT Data on Under-Represented Patients Guide
08/11/2023
 
 
TXT PAS Classification Category Guidance
08/10/2023
 
 
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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;
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