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FDA-RELATED NEWS
 
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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 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 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 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
 
 
TXT Drug Recalls Down, Device Recalls Up: Sedgwick
05/16/2024
 
 
TXT FDA Import Alert for Some Chinese Syringes
05/16/2024
 
 
TXT Accelerated Approval for Amgen Lung Cancer Drug
05/16/2024
 
 
TXT FDA OKs Roche HPV Self-Collection Solution
05/15/2024
 
 
TXT CGMP Violations in Health Specialty Inspection
05/15/2024
 
 
TXT 55 Novel Drugs Approved in 2023: Report
05/15/2024
 
 
TXT Juno Therapeutics’ Breyanzi Approved for Lymphoma
05/15/2024
 
 
TXT Rep Green Bill on Vaccine Data Transparency
05/15/2024
 
 
TXT FDA Marks Office of Women’s Health 30th Anniversary
05/15/2024
 
 
TXT Eisai Starts Rolling BLA for Leqembi Autoinjector
05/15/2024
 
 
TXT Change Pediatric Acetaminophen Directions: Petition
05/15/2024
 
 
TXT Abbott Recalls HeartMate 3 Pump Over Leaks
05/15/2024
 
 
TXT CGMP Violations in Grupo Contract Test Lab
05/14/2024
 
 
TXT FDA Warns Westwood Labs on CGMP Violations
05/14/2024
 
 
TXT Pull Yutrepia Tentative Approval: Petition
05/14/2024
 
 
TXT Federal Court Dismisses AcelRx Pharms Suit
05/14/2024
 
 
TXT Complete Response Letter for 4-Dose Heplisav-B
05/14/2024
 
 
TXT Indica Labs Digital Pathology Platform Cleared
05/14/2024
 
 
TXT Expiry Dates Extended on CTK Bio’s Covid Tests
05/14/2024
 
 
TXT Ascendis Pharma NDA Review Extended
05/14/2024
 
 
TXT FDA OKs Expanded Clinolipid Use
05/13/2024
 
 
TXT Respironics Recall of Trilogy Evo Ventilators
05/13/2024
 
 
TXT Novo Nordisk Filing BLA for Hemophilia A Drug
05/13/2024
 
 
TXT Warning on Cue Health’s Covid Tests
05/13/2024
 
 
TXT Eugia Sent 7-Item 483 After India Inspection
05/13/2024
 
 
TXT FDA Priority Review for Dupixent sBLA
05/13/2024
 
 
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 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 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 Bioresearch Monitoring Violations at DBC Research
05/07/2024
 
 
TXT Endo Paying $1.5 Billion Fines, Forfeitures
05/07/2024
 
 
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 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 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
 
 
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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