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FDA-RELATED NEWS
 
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TXT NEWSROOM CLOSED FOR THE HOLIDAYS
12/14/2024
 
 
TXT Zimmer Biomet Stemless Shoulder System
12/13/2024
 
 
TXT CDER Right-to-Try Summaries Can Go Thru Portal
12/13/2024
 
 
TXT Guide on Tech Specs for NASH Drug Data Sets
12/13/2024
 
 
TXT FDA Promotes Centralized Statistical Trial Monitoring
12/13/2024
 
 
TXT McKinsey & Co. Pays $650 Million in Opioid Case
court
12/13/2024
 
 
TXT DTC Ad Enforcement to Increase Under Trump: Panel
12/12/2024
 
 
TXT FDA Sees New Ocaliva Liver Injuries
12/12/2024
 
 
TXT FDA Hasn’t Inspected Factory with Recalls: ProPublica
12/12/2024
 
 
TXT Trump Unclear on Abortion Pills in Interview
12/12/2024
 
 
TXT Generics Seek Legislation to End Drug Sameness Delays
12/12/2024
 
 
TXT U.S. Approves More New Drugs than EU, Japan: Analysis
12/12/2024
 
 
TXT J&J Impella Heart Pumps Get Expanded Indications
12/12/2024
 
 
TXT Regulating AI in Healthcare: Paragon White Paper
12/11/2024
 
 
TXT Fresenius Kabi Pump Early Alert
12/11/2024
 
 
TXT Stakeholders Comment on Patient Preference Guide
12/11/2024
 
 
TXT Furosemide Injection sNDA Faces Submission Delay
12/11/2024
 
 
TXT CDER Wants AI Use in Drug Safety: Attorneys
12/11/2024
 
 
TXT Advisory Panel to Discuss Pediatric RSV Vaccine Safety
12/11/2024
 
 
TXT NIH Ends Mpox Study Early
12/11/2024
 
 
TXT Carvykti Shows Favorable Minimal Residual Disease Data
12/10/2024
 
 
TXT OCI Case Nets 2 on HIV, Covid Drug Convictions
12/10/2024
 
 
TXT CGMP Violations at China’s Guangzhou Four E’s
12/10/2024
 
 
TXT Getinge/Maquet Recalls VasoView HemoPro 2
12/10/2024
 
 
TXT FDA Stem Cell Regulation Court Ruling Analyzed
12/10/2024
 
 
TXT FDA Denies Metacel Ozobax Petition
12/10/2024
 
 
TXT ICH Model-Informed Drug Development Guide Out
12/10/2024
 
 
TXT Favorable Pirtobrutinib Data in Leukemia/Lymphoma: Lilly
12/10/2024
 
 
TXT Update on Baxter Recall of Hemodialysis Transfer Sets
12/09/2024
 
 
TXT GSK Files for Nucala COPD Indication
12/09/2024
 
 
TXT Mixed Results on Keytruda Ovarian Cancer Study
12/09/2024
 
 
TXT FDA Clears Prostate Tissue Ablator
12/09/2024
 
 
TXT AbbVie Reports Positive Parkinson’s Trial Data
12/09/2024
 
 
TXT Chimerix Plans Accelerated Approval NDA for Gliomas Drug
12/09/2024
 
 
TXT Fresenius Hit With 11-Item FDA-483
12/09/2024
 
 
TXT e-Submission Guide for BIMO Inspection Planning
12/06/2024
 
 
TXT Panel to Discuss Opioid Abuse Studies
12/06/2024
 
 
TXT Drug/Biologic Accelerated Approval Draft Guide
12/06/2024
 
 
TXT GE Healthcare Recalls Newborn Incubators
12/06/2024
 
 
TXT Groups Urge Rare Disease Voucher Reauthorization
12/06/2024
 
 
TXT FDA Loses Again in FOIA Suit on Vaccine Records
12/06/2024
 
 
TXT FDA Finds Lab Issues at Musk Plant
12/05/2024
 
 
TXT Updated Accelerated Approval Guidance
12/05/2024
 
 
TXT FDA Approves AZ’s Lung Cancer Drug Imfinzi
12/05/2024
 
 
TXT Rayner Wants Generic Omidria Restrictions
12/05/2024
 
 
TXT Protara Reports Positive Data on Bladder Cancer Drug
12/05/2024
 
 
TXT EpicentRx Gets Fast Track for Sarcoma Therapy
12/05/2024
 
 
TXT Breakthrough Status for Ventricular Tachycardia Ablator
12/05/2024
 
 
TXT Shortage of Empty IV Containers
12/04/2024
 
 
TXT FDA Clears Zimmer Persona Femur
12/04/2024
 
 
TXT Merus’ Bizengri Wins Accelerated Approval
12/04/2024
 
 
TXT Drug-Induced Liver Injury Indicator Seen: FDA
12/04/2024
 
 
TXT Require Prednisolone Solution Studies: DifGen
12/04/2024
 
 
TXT Clinical Investigator Didn’t Meet Requirements: FDA
12/04/2024
 
 
TXT Draft Guide on Antibacterial Bovine Drugs
12/04/2024
 
 
TXT Guide on Change Control Plans for AI Devices
12/04/2024
 
 
TXT Lilly’s Zepbound Shows Superiority Over Wegovy: Trial
12/04/2024
 
 
TXT Breakthrough Status for Dravet Therapy
12/04/2024
 
 
TXT CGMP Violations at Zhejiang Uniquality
12/03/2024
 
 
TXT Roivant Scraps Sarcoidosis Drug After Failed Trial
12/03/2024
 
 
TXT FDA 2024 Guidance Report and Best Practices
12/03/2024
 
 
TXT Predetermined Change Control Plan Guide
12/03/2024
 
 
TXT Multiple Violations at S. Korea’s LCC Ltd.
12/03/2024
 
 
TXT Merck Breakthrough Status for Lung Cancer Drug
12/03/2024
 
 
TXT House Covid Report Hits FDA, Others
12/03/2024
 
 
TXT Applied Therapeutics Faulted for Trial Conduct
12/03/2024
 
 
TXT Baxter Recalls AK 98 Dialysis Machines
12/02/2024
 
 
TXT Guide on Circulating Tumor DNA Biomarker Trials
12/02/2024
 
 
TXT Gottlieb Worried About RFK Jr. Pick for HHS
12/02/2024
 
 
TXT J&J Seeks Tremfya Approval for Pediatric Uses
12/02/2024
 
 
TXT Applied Therapeutics NDA Denied Approval
12/02/2024
 
 
TXT FDA OKs Mentor's Larger Breast Implants
12/02/2024
 
 
TXT Circulating Tumor DNA Use Guidance
11/27/2024
 
 
TXT Patheon Italia FDA-483 Out
11/27/2024
 
 
TXT Guide on Assessing Ovarian Toxicity
11/27/2024
 
 
TXT 8 GDUFA Science and Research Priorities
11/27/2024
 
 
TXT PTC Trial in ALS Patients Misses Endpoint
11/27/2024
 
 
TXT FDA Alert on Skysona Hematologic Malignancies
11/27/2024
 
 
TXT Soleno NDA Review Extended by 3 Months
11/26/2024
 
 
TXT Device Sterilization Enforcement Discretion Guide
11/26/2024
 
 
TXT Let FDA Set AI Postmarket Standards: Califf
11/26/2024
 
 
TXT Multiple Adept Medical Violations Cited
11/26/2024
 
 
TXT CGMP Violations at Italy’s Eurosirel
11/26/2024
 
 
TXT Oncologic Drugs Ovarian Toxicity Guidance
11/26/2024
 
 
TXT Court Tosses Attorney’s Privacy Suit Against FDA
11/26/2024
 
 
TXT Follow-up Testing for Ames-Positive Drugs: Guide
11/26/2024
 
 
TXT Trump Selects Johns Hopkins Makary as FDA Head
11/25/2024
 
 
TXT Device EtO Sterilization Transitional Enforcement Policy
11/25/2024
 
 
TXT Zimmer Biomet Cementless Partial Knee OK’d
11/25/2024
 
 
TXT Cassava Stops Controversial Alzheimer’s Drug Developoment
11/25/2024
 
 
TXT Neurogene Gene Therapy Patient Dies After Dosing
11/22/2024
 
 
TXT Endo Recalls Clonazepam Due to Mislabeling
11/22/2024
 
 
TXT FDA Research Links Montelukast to Mental Issues
11/22/2024
 
 
TXT Jazz Biliary Tract Cancer BLA Approved
11/22/2024
 
 
TXT 2 Orthopedic Non-Spinal Bone Guidances Posted
11/22/2024
 
 
TXT CDRH New Pilot on High-Risk Recalls
11/21/2024
 
 
TXT MXBBB Recalls Umary Hyaluronic Acid Tablets
11/21/2024
 
 
TXT Over 290 OCI Arrests in FY 2023: FDA
11/21/2024
 
 
TXT ‘Burdensome’ Device Assessment Guidance: Post
11/21/2024
 
 
TXT Johns Hopkins Surgeon Eyed for FDA Top Job
11/21/2024
 
 
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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