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FDA-RELATED NEWS
 
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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 9 Applicants Chosen for Drug Quality Evaluation
04/11/2024
 
 
TXT Oncolytics Wants FDA Meeting on Pelareorep
04/11/2024
 
 
TXT 6 Observations in Cipla FDA-483
04/11/2024
 
 
TXT Roche Alzheimer’s Test is Breakthrough Device
04/11/2024
 
 
TXT Neurovalens Anxiety Device Cleared
04/11/2024
 
 
TXT Drug Shortages at Highest Level: ASHP
04/11/2024
 
 
TXT Califf Defends FDA Role in Patent Listings
04/11/2024
 
 
TXT Appeals Court Upholds Norwich ANDA Delay
04/11/2024
 
 
TXT FDA Complex Innovative Designs Meeting Praised
04/10/2024
 
 
TXT FDA OKs CAR-T Trial in Children for Lupus
04/10/2024
 
 
TXT Army Scientific Group’s Hemorrhage AI Detector Cleared
04/10/2024
 
 
TXT Italfarmaco Awarded Priority Review Voucher
04/10/2024
 
 
TXT Par Sues FDA Over BPI Epinephrine Approval
04/10/2024
 
 
TXT ODAC to Discuss Minimal Residual Disease Endpoint
04/10/2024
 
 
TXT Include Pregnant, Lactating Women in Trials: Report
04/10/2024
 
 
TXT Import Alert Against China Syringe Maker
04/10/2024
 
 
TXT Multiple Violations at Kilitch Healthcare India
04/09/2024
 
 
TXT CGMP Violations in Jiangsu Meifan Records Review
04/09/2024
 
 
TXT No Benefit in Many Cancer Accelerated Approvals
04/09/2024
 
 
TXT BrainStorm Gets FDA Buy-In on Special Protocol
04/09/2024
 
 
TXT Antaria API Deviations Cited
04/09/2024
 
 
TXT Vanda Case Could Produce Legislation: Report
04/09/2024
 
 
TXT 10 FDA Advisors Had Financial Ties with Abbott: KFF
04/09/2024
 
 
TXT Methodological Rigor Info May Help Promotions: OPDP
04/09/2024
 
 
TXT Alkem Labs Hit With 10-item Form-483
04/09/2024
 
 
TXT Philips Respironics Consent Decree Approved
04/09/2024
 
 
TXT ViiV Wins Adolescent HIV Use for Dovato
04/08/2024
 
 
TXT Spirair Nasal Septal Deviation Device Cleared
04/08/2024
 
 
TXT Carvykti Approved for Expanded Myeloma Use
04/08/2024
 
 
TXT FDA 2nd Complete Response on Parkinson’s Drug
04/08/2024
 
 
TXT De Novo for Antibacterial Coated Implants
04/08/2024
 
 
TXT Shuffert Debarred for 5 Years
04/05/2024
 
 
TXT Abecma Expanded Approval for Multiple Myeloma
04/05/2024
 
 
TXT Honeywell Recalls Eyewash Cartridge
04/05/2024
 
 
TXT Accelerated Approval for Enhertu in Solid Tumors
04/05/2024
 
 
TXT Jubilant Generics Cited Over GMPs
04/05/2024
 
 
TXT AbbVie Urges FDA to Ban Unlicensed Thyroid Products
04/05/2024
 
 
TXT Withdraw AvertD Approval: Scientists
04/04/2024
 
 
TXT 45 CDRH Safety Communications in 2022: Report
04/04/2024
 
 
TXT Medos Guide Sheath Recall is Class 1: FDA
04/04/2024
 
 
TXT Liquidia Expects FDA Yutrepia Final OK Soon
04/04/2024
 
 
TXT Novartis Seeking Expanded Pluvicto Label
04/04/2024
 
 
TXT FDA Cross-Center AI Paper Analyzed
04/04/2024
 
 
TXT Califf in Hot Seat at 4/11 Oversight Hearing
04/04/2024
 
 
TXT Amylyx Pulls ALS Drug From the Market
04/04/2024
 
 
TXT OPQ Supported 55 Novel Drug Approvals in 2023
04/03/2024
 
 
TXT Ignore Former FDAer’s Comments: Sidley
04/03/2024
 
 
TXT New Indication for Vanda’s Fanapt
04/03/2024
 
 
TXT Bipartisan Bill on Drug-Gene Interactions
04/03/2024
 
 
TXT Contract Pharma Cited on Environmental Issue
04/03/2024
 
 
TXT HHS Defines FDA Roles in Drug Shortages
04/03/2024
 
 
TXT Abbott's TriClip OK'd for Tricuspid Regurgitation
04/03/2024
 
 
TXT FDA Qualifies Lethal Arrhythmia Database
04/03/2024
 
 
TXT FDA OKs Zevtera Antibiotic with 3 Indications
04/03/2024
 
 
TXT Prenosis AI Sepsis Predictor Authorized for Use
04/03/2024
 
 
TXT More Changes Urged in RRA Revised Guidance Comments
04/02/2024
 
 
TXT CGMP Violations at Mexico’s Betone SA de CV
04/02/2024
 
 
TXT Multiple Agena Bioscience Violations
04/02/2024
 
 
TXT QS Issues in Beckman Coulter Inspection
04/02/2024
 
 
TXT 20 Safety Potential Signals in 4th Quarter 2023
04/02/2024
 
 
TXT Bill to Speed Addiction Drug Treatments
04/02/2024
 
 
TXT Bioavailability/Bioequivalence Data Integrity Guide
04/02/2024
 
 
TXT Mixed Data on Colon Cancer Vaccine
04/02/2024
 
 
TXT Characterize Obesity as a Chronic Disease: Lilly
04/02/2024
 
 
TXT FDA Increasing Scrutiny of CooperSurgical IUD: Report
04/02/2024
 
 
TXT FDA Developing New Drug Safety Tools: Dal Pan
04/02/2024
 
 
TXT Baxter Novum IQ Large Volume Pump Cleared
04/01/2024
 
 
TXT AstraZeneca’s Voydeya OK’d for Hemolysis
04/01/2024
 
 
TXT Eisai sBLA for Monthly Alzheimer’s Maintenance
04/01/2024
 
 
TXT FDA Guide on Safety Report e-Submissions
04/01/2024
 
 
TXT FDA Clears Abbott’s Concussion Blood Test
04/01/2024
 
 
TXT PhRMA Seeks Specificity for Cell Product Potency Guide
04/01/2024
 
 
TXT Guide on Dental Bone Grafting Devices
03/29/2024
 
 
TXT Thoratec Recalls HeartMate Touch Communication
03/29/2024
 
 
TXT eSTAR Now Available for Device 513(g) Requests
03/29/2024
 
 
TXT ProJenX Partial Hold Lifted in ALS Study
03/29/2024
 
 
TXT Poll Backs FDA Status Quo in Approving Products
03/29/2024
 
 
TXT Guidance on IND Safety Report eSubmissions
03/29/2024
 
 
TXT Review Extended on Govorestat NDA
03/29/2024
 
 
TXT Dental Bone Graft Animal Study Guide
03/28/2024
 
 
TXT FDA Approves Akebia Vafseo for Some Anemias
03/28/2024
 
 
TXT Aldeyra Plans for Reproxalap NDA Resubmission
03/28/2024
 
 
TXT 3-year-old Fusion IV FDA-483 Released
03/28/2024
 
 
TXT ASCA Pilot Met, Exceeded Expectations: CDRH
03/28/2024
 
 
TXT Amneal Recalls 4 Lots of Vancomycin
03/28/2024
 
 
TXT FDA OKs Expanded Use for Hepatitis B Drug
03/28/2024
 
 
TXT Medexus’ Hemophilia B Factor Gets Expanded Use
03/28/2024
 
 
TXT 2 REMS Assessment MAPPs
03/27/2024
 
 
TXT FDA ‘Fails to Follow Science’ in Electroshock Case: Attorneys
03/27/2024
 
 
TXT BIO Suggestions for CGT Potency Guidance
03/27/2024
 
 
TXT Catalent Indiana FDA-483
03/27/2024
 
 
TXT Merck BLA for Winrevair Approved
03/27/2024
 
 
TXT Proposed Ban on Certain e-Stimulation Devices
03/27/2024
 
 
TXT Weiner Moves to Foreign Inspections Office
03/27/2024
 
 
TXT Boston Scientific Recalls PolarSheath Steerable
03/27/2024
 
 
TXT FDA Approves Medtronic Evolut FX+
03/27/2024
 
 
TXT Revised BA/BE Sample Handling Guidance
03/26/2024
 
 
TXT Bioresearch Monitoring Issues at New York Site
03/26/2024
 
 
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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;
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