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FDA-RELATED NEWS
 
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TXT FDA Preliminary Assessment on OTC Naloxone
11/16/2022
 
 
TXT ‘Put Aduhelm Approval on Hold’: Researchers
11/16/2022
 
 
TXT CA Appeals Court Upholds Federal Preemption
11/16/2022
 
 
TXT FDA Updates Cybersecurity Playbook
11/15/2022
 
 
TXT Certain Naloxone Products Could be OTC: FDA
11/15/2022
 
 
TXT FDA Questions Ardelyx’ Tenapanor
11/15/2022
 
 
TXT Workshop on Using Consensus Standards in Device Submissions
11/15/2022
 
 
TXT 1 Observation on Athenex Pharma FDA-483
11/15/2022
 
 
TXT Comments on Computer Software Assurance Guidance
11/15/2022
 
 
TXT Warning Letter ‘Top 10’ GMP Deficiencies
11/15/2022
 
 
TXT Protalix, Chiesi Resubmit Fabry Disease BLA
11/14/2022
 
 
TXT Roche Alzheimer’s Drug Misses in 2 Phase 3 Studies
11/14/2022
 
 
TXT Satsuma Plans Migraine NDA After Data Miss
11/14/2022
 
 
TXT ImmunoGen’s Elahere OK’d for Several Cancers
11/14/2022
 
 
TXT Insulet Device Correction on ‘Melting’ Omnipod 5
11/14/2022
 
 
TXT FDA Clears Surgical Augmented Reality Software
11/14/2022
 
 
TXT Regulatory Review Period for Merck’s Prevymis
11/11/2022
 
 
TXT GSK Narrows Zejula Indication at FDA’s Request
11/11/2022
 
 
TXT FTC Takes Issue with Jazz Orange Book Listing
11/11/2022
 
 
TXT Imfinzi/Imjudo OK’d for Lung Cancer
11/11/2022
 
 
TXT ‘Device’ Definition Guidance
11/10/2022
 
 
TXT ICH Guide on Cell-line Product Viral Safety
11/10/2022
 
 
TXT Expedited Program Quality Assessment MAPP
11/10/2022
 
 
TXT Change Ethical Issues for Kids’ Products: AdvaMed
11/10/2022
 
 
TXT 2 Comments on Computer Software Assurance Guidance
11/10/2022
 
 
TXT FDA Refuses to File NurOwn BLA
11/10/2022
 
 
TXT Strengthen AI Product Approval: Researchers
11/10/2022
 
 
TXT 18 Observations on Lupin FDA-483
11/09/2022
 
 
TXT ImprimisRx NJ FDA-483 Has 9 Observations
11/09/2022
 
 
TXT Reject FDA Privilege Claim in FOIA Case: WLF
11/09/2022
 
 
TXT RapidAI’s Lastest Version of Rapid ICH Cleared
11/09/2022
 
 
TXT Insulet Diabetes Manager Correction
11/09/2022
 
 
TXT Panel Backs AstraZeneca Asthma Product in Adults
11/09/2022
 
 
TXT ZoomRx Keys to Better Oncology Promo Messaging
11/09/2022
 
 
TXT NatureLab Adulterated and Misbranded Dietary Supplements
11/08/2022
 
 
TXT CGMP Violations at Abraxis Bioscience
11/08/2022
 
 
TXT ANDA Sameness Evaluation Guidance
11/08/2022
 
 
TXT FDA Raises Sabizabulin ‘Uncertainties’
11/08/2022
 
 
TXT Omeros Loses Appeal on Stem Cell Transplant Drug
11/08/2022
 
 
TXT Drug-Device Combo Firms Quiz FDA on Specs
11/08/2022
 
 
TXT Start Device Covid Transition Plans Now: Attorneys
11/08/2022
 
 
TXT FDA Seeks New Accelerated Approval Requirement
11/08/2022
 
 
TXT 7 Combination Product Guidances on the Way
11/08/2022
 
 
TXT Device Postmarket Surveillance Info Collection
11/07/2022
 
 
TXT BioMarin Asked to Submit New Data on Gene Therapy
11/07/2022
 
 
TXT Guide on Early Studies on Cell/Gene Therapies
11/07/2022
 
 
TXT Guide on Bioanalytical Method Validation
11/07/2022
 
 
TXT GSK Blenrep Phase 3 Misses Primary Endpoint
11/07/2022
 
 
TXT FDA Places Hold on Verve Hypercholesterolemia Drug
11/07/2022
 
 
TXT Verrica Pharma Refiling NDA for VP-102
11/07/2022
 
 
TXT Guide on Studying Multiple Cell/Gene Therapies
11/04/2022
 
 
TXT Apellis Pharma NDA Review Extended on New Data
11/04/2022
 
 
TXT New MDIC Framework on Device Trials
11/04/2022
 
 
TXT 21 State AGs Urge FDA OK of OTC Birth Control
11/04/2022
 
 
TXT Guide on Bioanalytical Method Validation
11/04/2022
 
 
TXT Lifting Barriers to Transgender People in Cancer Trials
11/03/2022
 
 
TXT Safety Alert on Infant Head Shaping Pillows
11/03/2022
 
 
TXT Panel OKs CDER Quality Management Maturity Program
11/03/2022
 
 
TXT GSK Stops UTI Trials and Opts for NDA
11/03/2022
 
 
TXT FDA, Others Launch Global Substances System
11/03/2022
 
 
TXT Califf Touts Progress in Drug Compounding Oversight
11/03/2022
 
 
TXT Updated Meeting Definitions
11/03/2022
 
 
TXT Guidance on Oncology Cross-Labeling
11/03/2022
 
 
TXT Guidance on Pharmaceutical Carcinogenicity Testing
11/02/2022
 
 
TXT Oncology Drug Cross Labeling Guidance
11/02/2022
 
 
TXT Teleflex Filter Recall is Class 1
11/02/2022
 
 
TXT Temporary Clozapine REMS Enforcement Discretion
11/02/2022
 
 
TXT Guilty Pleas in Drug Kickback Conspiracy
11/02/2022
 
 
TXT New Requests in Radius Petition Supplement
11/02/2022
 
 
TXT Petition Seeks Reclassification of BD Mesh/Scaffolds
11/02/2022
 
 
TXT Lawmakers Question FDA on Canadian Drug Importation
11/02/2022
 
 
TXT Comments on FDA ‘Medical Queries’
11/01/2022
 
 
TXT Amazon Distributing Misbranded, Unapproved Drugs: FDA
11/01/2022
 
 
TXT Comments on ICH Pediatric Extrapolation Guidance
11/01/2022
 
 
TXT Revised Expanded Access Q&A Guidance
11/01/2022
 
 
TXT Don’t Approve Some Tc-99m NDAs: Petition
11/01/2022
 
 
TXT CGMP Violations at Lupin Limited
11/01/2022
 
 
TXT Use of Expedited Drug Review Programs Increasing
11/01/2022
 
 
TXT FDA Defers Action on Amicus BLA
11/01/2022
 
 
TXT Pfizer Plans BLA for RSV Vaccine
11/01/2022
 
 
TXT ICH Guide Aims to Reduce Rat Carcinogenic Studies: FDA
11/01/2022
 
 
TXT FDA Revises EUAs for Covid Serial Testing
11/01/2022
 
 
TXT Measuring Growth and Evaluating Pubertal Development Guide
10/31/2022
 
 
TXT BMS’ Reblozyl Meets Endpoint in Anemia Patients
10/31/2022
 
 
TXT FDA Helping Philips to Resolve MRI-related Shortages
10/31/2022
 
 
TXT FDA Alert on Tracheostomy Tube Shortages
10/31/2022
 
 
TXT FDA Rejects Gilead Hepatitis Delta BLA
10/28/2022
 
 
TXT FDA Relaxes Promotion Restrictions on Covid EUAs
10/28/2022
 
 
TXT Advisory Panel Shoots Down Y-mAbs BLA
10/28/2022
 
 
TXT FDA Advancing Treatments for Children
10/27/2022
 
 
TXT FDA Questions Y-mAbs Neuroblastoma Treatment Efficacy
10/27/2022
 
 
TXT Digital Health Regulatory Science Opportunities
10/27/2022
 
 
TXT Panel Mixed on GSK Anemia Drug Due to Safety
10/27/2022
 
 
TXT California Court Upholds Preemption for Medtronic
10/27/2022
 
 
TXT Ashley Retiring as CDER Compliance Director
10/27/2022
 
 
TXT FDA Looking at Marijuana Scheduling Flexibility: Woodcock
10/27/2022
 
 
TXT Positive Results in AZ Breast Cancer Trials
10/26/2022
 
 
TXT FY 2023 GDUFA Research Priorities
10/26/2022
 
 
TXT Baxter WatchCare Urgent Correction
10/26/2022
 
 
TXT Developing, Responding to Device Deficiencies Guidance
10/26/2022
 
 
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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
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