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FDA-RELATED NEWS
 
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TXT AskBio Gets Fast Track for Parkinson’s Gene Therapy
07/12/2024
 
 
TXT Mainz Seeks Breakthrough Status for Colon Cancer Test
07/19/2024
 
 
TXT Device Chemical Analysis for Biocompatibility
07/19/2024
 
 
TXT Diamyd Granted Fast Track for Diabetes
07/19/2024
 
 
TXT Spectralis Optical Coherence Tomography Module Cleared
07/19/2024
 
 
TXT Phelan-McDermid Therapy Given Rare Disease Status
07/19/2024
 
 
TXT 7 Observations in Leiters Health FDA-483
07/18/2024
 
 
TXT FDA ‘Discourages’ BOT/BAL Accelerated Approval
07/18/2024
 
 
TXT Zydus Gets ‘Official Action Indicated’ on Recent Inspection
07/18/2024
 
 
TXT Aveo Phase 3 Trial Misses Primary Endpoint
07/18/2024
 
 
TXT Breakthrough Status for Heart Failure Device
07/18/2024
 
 
TXT Phathom Pharma Heartburn Drug Expanded Use
07/18/2024
 
 
TXT 2 More Warning Letters for Chinese Plastic Syringes
07/18/2024
 
 
TXT Human Radiolabeled Mass Balance Study Guide
07/18/2024
 
 
TXT Baxter Recalls Volara System Ventilator Adapter
07/17/2024
 
 
TXT Comments Extended for Guide on Platform Technology
07/17/2024
 
 
TXT FDA Opening Rare Disease Innovation Hub
07/17/2024
 
 
TXT Blood Donor Eligibility Compliance Policy
07/17/2024
 
 
TXT Endo Recalls 1 Lot of Clonazepam
07/17/2024
 
 
TXT Bayer Looking to Expand Nubeqa Indication
07/17/2024
 
 
TXT Priority Review for Atara Gene Therapy
07/17/2024
 
 
TXT Almost 3,000 Establishment Inspections in FY 2023
07/17/2024
 
 
TXT Philips Updates Ventilator Instructions
07/17/2024
 
 
TXT GMP Violations in YangZhou Records Review
07/16/2024
 
 
TXT CGMP Violations at Jiangsu Hengrui
07/16/2024
 
 
TXT Combination Product Application User Fees
07/16/2024
 
 
TXT FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug
07/16/2024
 
 
TXT Guidance on Pediatric IBD Drug Development
07/16/2024
 
 
TXT FDA Wants to Stem Common Chronic Diseases: Califf
07/16/2024
 
 
TXT Smith+Nephew New Hip System Cleared
07/16/2024
 
 
TXT Issues in MIT Institutional Review Board
07/16/2024
 
 
TXT Orexo Complete Response on Naloxone NDA
07/16/2024
 
 
TXT Rare Pediatric Disease Status for Leukemia Drug
07/16/2024
 
 
TXT Priority Voucher Used for Vyvgart Hytrulo sNDA
07/16/2024
 
 
TXT Extrapolating Partial Onset Seizure Drug Data
07/15/2024
 
 
TXT Lexeo Seeks Accelerated Approval for Cardiomyopathy Drug
07/15/2024
 
 
TXT Pharma Marketer Sentenced in Compounding Scheme
07/15/2024
 
 
TXT CDRH Announces Organizational Changes
07/15/2024
 
 
TXT Baxter Recalls Life200 Ventilators
07/15/2024
 
 
TXT Lonza Swiss Facility Gets FDA-483
07/15/2024
 
 
TXT Gene Therapy Interactive Site Tours Program
07/15/2024
 
 
TXT Rinvoq sNDA for Giant Cell Arteritis Filed
07/12/2024
 
 
TXT Gottlieb Calls for Congress’ Help with AI Device Regulation
07/12/2024
 
 
TXT Indivior Pulls Plug on Schizophrenia Drug Marketing
07/12/2024
 
 
TXT Hamilton Medical Recalls Ventilators
07/11/2024
 
 
TXT Baxter Recalls Life2000 Ventilators
07/11/2024
 
 
TXT 3 Observations on Hikma FDA-483
07/11/2024
 
 
TXT 5 Themes in Innovative Trial Approach Meeting
07/11/2024
 
 
TXT Pfizer Taps Oral Danuglipron Formulation for Obesity
07/11/2024
 
 
TXT Complete Response on Novo Nordisk Insulin Icodec
07/11/2024
 
 
TXT 2 Draft Dental Device Guidances Out
07/11/2024
 
 
TXT Senate Gives FDA $170 Million Boost for FY 2025
07/11/2024
 
 
TXT Opioid Treatment Devices Study Guidance
07/10/2024
 
 
TXT Kazia Touts Glioblastoma Drug Trial Results
07/10/2024
 
 
TXT Workshop on AI in Drug/Biologic Development
07/10/2024
 
 
TXT FDA Clears ImmersiveAR for OR Use
07/10/2024
 
 
TXT CBER Staff Guide on IND Processing, Review
07/10/2024
 
 
TXT Change Device Enforcement Guide: AdvaMedDx
07/10/2024
 
 
TXT Payers Should Help in Evidence Generation: Report
07/10/2024
 
 
TXT Arcutis Biotherapeutics’ Zoryve OK’d for Atopic Dermatitis
07/10/2024
 
 
TXT Regenerative Medicine Designation for Alzheimer’s Therapy
07/10/2024
 
 
TXT CGMP Violations at S. Korea’s ReBom Co.
07/09/2024
 
 
TXT Inspire Recalls Implantable Pulse Generator
07/09/2024
 
 
TXT Optikem CGMP Violations Cited
07/09/2024
 
 
TXT CBER Updates 2024 Guidance Agenda
07/09/2024
 
 
TXT Elevar Resubmitting Cancer Drug NDA
07/09/2024
 
 
TXT 30 1st Quarter Serious Risk Signals
07/09/2024
 
 
TXT FDA OKs Cordis Vascular Closure Device
07/09/2024
 
 
TXT Don’t Use Medtronic NIM EMG Endotracheal Tubes: FDA
07/09/2024
 
 
TXT UniQure Seeking Accelerated Approval Path for Gene Therapy
07/09/2024
 
 
TXT Philips Recalls Sense XL Torso MRI Coils
07/08/2024
 
 
TXT Groups Want Changes in Drug Labeling Guidance
07/08/2024
 
 
TXT Magellan Guilty Plea Over Misbranded Devices
07/08/2024
 
 
TXT Checkpoint Resubmits Cosibelimab BLA
07/08/2024
 
 
TXT FDA OKs Pyzchiva as Stelara Biosimilar
07/08/2024
 
 
TXT FDA OKs Genentech’s Vabysmo Syringe
07/08/2024
 
 
TXT FDA Drops Interchangeability Switching Studies
07/08/2024
 
 
TXT CGMP Violations in Sun Pharmaceutical Inspection
07/08/2024
 
 
TXT Opportunities, Risks in SCOTUS End to Chevron Deference: Lawyers
07/08/2024
 
 
TXT Web Site Illegally Selling Semaglutide Products: FDA
07/08/2024
 
 
TXT FDA OKs New Lilly Alzheimer’s Drug
07/08/2024
 
 
TXT Plan Now to Adopt FDA Trial Diversity Guide: Lawyers
07/08/2024
 
 
TXT ICH M14 Pharmacoepidemiological Studies Guide
07/08/2024
 
 
TXT Device Total Product Life Cycle Advisory Program Continues
07/08/2024
 
 
TXT Guidance on Addressing Regulated Product Misinformation
07/08/2024
 
 
TXT Guide on Combo Product Risk Analyses
07/08/2024
 
 
TXT FDA WEBVIEW CLOSED JULY 4TH WEEK
06/29/2024
 
 
TXT Brookfield Medical/Surgical FDA-483
06/28/2024
 
 
TXT Complete Response on Rocket Gene Therapy
06/28/2024
 
 
TXT Praise for Biological Labeling Draft Guidance
06/28/2024
 
 
TXT Drug Delivery Device Guidance
06/28/2024
 
 
TXT Philips Updates BiPAP Ventilator Use Instructions
06/28/2024
 
 
TXT SCOTUS Chevron Decision Harms the Public: Coalition
06/28/2024
 
 
TXT Abbott Recalls HeartMate System Monitor
06/28/2024
 
 
TXT 6 Observations in Cipla FDA-483
06/27/2024
 
 
TXT FDA Opening Office in Rwanda
06/27/2024
 
 
TXT FDA Modifies CAR T Cell REMS
06/27/2024
 
 
TXT Draft Guide on Diversity Action Plans
06/27/2024
 
 
TXT Complete Response on BLA for Lung Cancer Combo
06/27/2024
 
 
TXT Schakowsky Introduces Drug Import Bill
06/27/2024
 
 
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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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