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FDA-RELATED NEWS
 
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TXT Lawyer’s Motion to Remain Anonymous Granted
05/23/2023
 
 
TXT FDA OK’s New Opioid Use Disorder Option
05/23/2023
 
 
TXT Abbott Touts Data on Dual Chamber Pacemaker
05/23/2023
 
 
TXT FDA Approval Reciprocity Bill Reintroduced
05/23/2023
 
 
TXT FDA Denies Petition for PPI Pneumonia Warning
05/23/2023
 
 
TXT Contract Testing Lab Gets Warning Letter
05/23/2023
 
 
TXT New FDA MOU for Distributed Manufacturing
05/23/2023
 
 
TXT Figures in Tellus Clinical Trial Fraud Case Acquitted
05/23/2023
 
 
TXT Petition for Warning on Diabetes Drugs Denied
05/22/2023
 
 
TXT CDRH Portal Expanded to Pre-Submission Feedback
05/22/2023
 
 
TXT Novo Nordisk Plans NDA for Oral Obesity Drug
05/22/2023
 
 
TXT Rain Oncology Scraps Milademetan
05/22/2023
 
 
TXT FDA OKs Opiant Pharma’s Opioid Overdose Spray
05/22/2023
 
 
TXT FDA Issues 483 to Aurobindo API Facility
05/19/2023
 
 
TXT DTC Research Supports Disclosures on Endpoint Differentiation
05/19/2023
 
 
TXT Abiomed Recalls Impella 5.5. Blood Pump
05/19/2023
 
 
TXT Zoll Settles Case Against China-made ECG Cables
05/19/2023
 
 
TXT Topical Gene Therapy for Wounds Approved
05/19/2023
 
 
TXT ‘Bionic Pancreas’ Cleared by FDA
05/19/2023
 
 
TXT Revoke Approval for MSN’s Generic Hetlioz: Vanda
05/18/2023
 
 
TXT Nephron Pharmaceuticals Warehouse FDA-483
05/18/2023
 
 
TXT AbbVie Gets Rinvoq OK for Crohn’s
05/18/2023
 
 
TXT Draeger Recalls Seattle CPAP Device and Components
05/18/2023
 
 
TXT Child Cancer Research Bill Reintroduced
05/18/2023
 
 
TXT House Dems Working on Cancer Drug Shortage
05/18/2023
 
 
TXT Appropriators Cut FDA Budget by $600 million
05/18/2023
 
 
TXT Panel Backs Pfizer’s RSV Vaccine
05/18/2023
 
 
TXT 2 Pediatric Drug Approval Guidances
05/17/2023
 
 
TXT ICU Medical Recalls Pumps Over Battery Defect
05/17/2023
 
 
TXT Device Panel to Tackle Health Equity
05/17/2023
 
 
TXT Reviewers Question Intercept’s Liver Drug
05/17/2023
 
 
TXT Bill to Use Industry Penalties for Cancer Research
05/17/2023
 
 
TXT Califf Hopeful on Alzheimer’s, Obesity Drug Data
05/17/2023
 
 
TXT Drug Company Patent Violations Cost $40 Billion: Study
05/17/2023
 
 
TXT Reject Apotex Generic Fintepla ANDA: UCB
05/17/2023
 
 
TXT Prothena Adds Ex-FDA Neuroscience Head to Board
05/17/2023
 
 
TXT Attorney Sues FDA to Keep Name Off FDA-483
05/17/2023
 
 
TXT Pharmedica CGMP Violations Result in Plant Shutdown
05/16/2023
 
 
TXT Ipca Laboratories FDA-483
05/16/2023
 
 
TXT FDA Issues with Sea-Long Medical Treatment Hoods
05/16/2023
 
 
TXT Bespoke Gene Therapy Portfolio has 8 Diseases
05/16/2023
 
 
TXT Let Compounders Help with Drug Shortages: Op-Ed
05/16/2023
 
 
TXT Did Recarbrio Approval Break FDA Rules?
05/16/2023
 
 
TXT Judge Hits Precision Lens with $487 Million Fine
05/16/2023
 
 
TXT Abbott Spinal Stimulation Devices OK for Back Pain
05/16/2023
 
 
TXT Comments on Electronic Systems Q&A Draft
05/16/2023
 
 
TXT Byondis BLA on Breast Cancer Therapy Rejected
05/15/2023
 
 
TXT Supreme Court Turns Down Skinny Label Case
05/15/2023
 
 
TXT Split Vote on Sarepta Gene Therapy
05/15/2023
 
 
TXT Pedicle Screw Bone Awl Cleared
05/15/2023
 
 
TXT Guide on Reporting Animal Drug Shortages
05/15/2023
 
 
TXT Orphan Status for Pyxis Pancreatic Cancer Therapy
05/12/2023
 
 
TXT Cordis Class 1 Recall of Angioguard System
05/12/2023
 
 
TXT Congress Urges More FDA Attention to Rare Diseases
05/12/2023
 
 
TXT FDA Encourages Voluntary Device Shortage Notices
05/12/2023
 
 
TXT Panel Backs Epinephrine Nasal Spray
05/12/2023
 
 
TXT FDA Eases Blood Donor HIV Recommendations
05/11/2023
 
 
TXT Cook Tracheostomy Introducer Recall is Class 1
05/11/2023
 
 
TXT FDA OKs Rexulti for Alzheimer’s Agitation
05/11/2023
 
 
TXT More Groups, Experts Back KEI Ad Music Petition
05/11/2023
 
 
TXT FDA Planning for Future Public Health Issues
05/11/2023
 
 
TXT Sibel Health Infant Monitor Cleared
05/11/2023
 
 
TXT Complete Response on Bladder Cancer BLA
05/11/2023
 
 
TXT PhRMA on FDA Negative Controls Workshop
05/11/2023
 
 
TXT CRN Asks FDA to Reconsider Drug Preclusion
05/11/2023
 
 
TXT Abbott MRI Labeling OK’d for Spinal Stimulator
05/11/2023
 
 
TXT Study Data Technical Conformance Guide
05/11/2023
 
 
TXT Stakeholder Ideas on FDA Electronic System Draft
05/11/2023
 
 
TXT FDA Wants Updated Labeling on Some Stimulants
05/11/2023
 
 
TXT Panel to Discuss Pediatric Oncology Dose Optimization
05/10/2023
 
 
TXT CDER Publishes AI/ML Discussion Paper
05/10/2023
 
 
TXT Reviewers Question Sarepta DMD Drug
05/10/2023
 
 
TXT Bill Would Force Drug Research Cost Disclosure
05/10/2023
 
 
TXT FDA Clears Renuvion Handpiece
05/10/2023
 
 
TXT Panel Unanimously Backs OTC Contraceptive Pill
05/10/2023
 
 
TXT Glycol Testing Guidance
05/09/2023
 
 
TXT CGMP Violations in Premier Nutra Pharma Inspection
05/09/2023
 
 
TXT Court Backs FDA in Somatuline Depot Case
05/09/2023
 
 
TXT FDA Clears Cumulus EEG Headset
05/09/2023
 
 
TXT AI/ML Predetermined Change Control Plan Guidance
05/09/2023
 
 
TXT FDA Reviewers Question ARS-1 Development Program
05/09/2023
 
 
TXT Clinical Hold Lifted on Diarrhea Trials
05/08/2023
 
 
TXT Singlera ‘Breakthrough’ on Pancreatic Cancer Assay
05/08/2023
 
 
TXT 2-Day Workshop on Generic Research Iniitiatives
05/08/2023
 
 
TXT Samsung Irregular Heart Monitor on Watch Cleared
05/08/2023
 
 
TXT De Novo Marketing of 2 Covid Serology Tests
05/08/2023
 
 
TXT Califf Warns of Regulation of Large Language Models
05/08/2023
 
 
TXT FDA Releases Sun Non-compliance Letter
05/08/2023
 
 
TXT New Web Page on Antimicrobial Susceptibility Tests
05/05/2023
 
 
TXT Fibrogen Misses Endpoint in Roxadustat Anemia Trial
05/05/2023
 
 
TXT FDA Issues Ajinomoto Bio-Pharma 3-item 483
05/05/2023
 
 
TXT PhRMA, Others Petition Against Drug Importation
05/05/2023
 
 
TXT Actual Use Study Flagged in OTC Birth Control NDA
05/05/2023
 
 
TXT Levitra Not Withdrawn Due to Safety/Efficacy
05/04/2023
 
 
TXT Guide on Decentralized Clinical Trials
05/04/2023
 
 
TXT Reject Rexulti Alzheimer’s sNDA: Public Citizen
05/04/2023
 
 
TXT Name NIH in Drug Patent Applications: GAO
05/04/2023
 
 
TXT Xortx to Pursue Accelerated Approval for Xorlo
05/04/2023
 
 
TXT Device Regulatory Science Tool Catalog Update
05/04/2023
 
 
TXT Califf Recommends FDA Reforms for Pandemic Bill
05/04/2023
 
 
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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;
  • 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