FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
<< Prev  28 29 30 31 32 33 34 35 36 37 38 39 40 41 Next >>
 
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
 
 
TXT MDIC Cybersecurity Maturity Benchmark Report
10/26/2022
 
 
TXT Califf Hoping for LDT Legislation
10/26/2022
 
 
TXT FDA Postpones Meeting on OTC Birth Control Pill
10/26/2022
 
 
TXT Priority Review for Seres BLA for c.diff Therapy
10/26/2022
 
 
TXT CGMP Violations at Nephron SC
10/25/2022
 
 
TXT Panel Reviewing Ipsen NDA Postponed
10/25/2022
 
 
TXT CGMP, Other Violations at Advanced Cosmetic Lab
10/25/2022
 
 
TXT Jubilant Generics FDA-483
10/25/2022
 
 
TXT NeuroOne Medical Brain Electrodes Get Clearance
10/25/2022
 
 
TXT FDA Explains Why Zepzelca Will Not be Withdrawn
10/25/2022
 
 
TXT FDA Airs Daprodustat Safety Concerns
10/25/2022
 
 
TXT FDA Nixes Cefazolin as Surrogate Agent for Cephalosporins
10/24/2022
 
 
TXT Warning Letter Close Out for Innova Medical
10/24/2022
 
 
TXT Gormley Adds Oncology Endpoint Role at FDA
10/24/2022
 
 
TXT AI Ultrasound Gains De Novo Backing for Nerve Block
10/24/2022
 
 
TXT Catalent Brussels Plant Inspected Again
10/24/2022
 
 
TXT Guide on Gene Therapies for Neurodegenerative Diseases
10/21/2022
 
 
TXT Bristol Myers sNDA for Camzyos
10/21/2022
 
 
TXT Paper Calls for FDA Reforms on Transparency/Evidence
10/21/2022
 
 
TXT Medtronic Pacing Lead Gets Expanded Labeling
10/21/2022
 
 
TXT Multiple Clinical Trial Endpoints Guidance
10/20/2022
 
 
TXT Talaris Reports FREEDOM-1 Study Death
10/20/2022
 
 
TXT ImClone Systems FDA-483
10/20/2022
 
 
TXT Don’t Wait for SBOM Finalization: Fu
10/20/2022
 
 
TXT Breakthrough Device Guidance Updates
10/20/2022
 
 
TXT PhRMA Raises QMM, KASA Issues
10/20/2022
 
 
TXT FDA Launches Advancing RWE Program
10/19/2022
 
 
TXT PTC Says Huntingdon’s Trial ‘Paused’ in the U.S.
10/19/2022
 
 
TXT Philips Mask Recall is Class 1
10/19/2022
 
 
TXT UDI Enforcement Policy, Alternatives FAQs
10/19/2022
 
 
TXT FDA Panel Shoots Down Makena’s Continued Availability
10/19/2022
 
 
TXT OMB Approves 5 Information Collections
10/19/2022
 
 
TXT Advisory Panel Rescheduled for Covid Therapy
10/19/2022
 
 
TXT FDA Awards 5 Biosimilars Research Grants
10/19/2022
 
 
TXT Torrent Pharmaceuticals FDA-483
10/19/2022
 
 
TXT ‘Uneven Readiness’ Seen for Supply Chain Law
10/19/2022
 
 
<< Prev  28 29 30 31 32 33 34 35 36 37 38 39 40 41  Next >>
 
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