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FDA-RELATED NEWS
 
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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 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 Comments on FDA ‘Medical Queries’
11/01/2022
 
 
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 Measuring Growth and Evaluating Pubertal Development Guide
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 FDA Explains Why Zepzelca Will Not be Withdrawn
10/25/2022
 
 
TXT FDA Airs Daprodustat Safety Concerns
10/25/2022
 
 
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 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
 
 
TXT Jail for 2 Women in Clinical Trial Data Case
10/19/2022
 
 
TXT Quality System, Other Violations at Forcemech
10/18/2022
 
 
TXT New FDA Rare Disease Grants, Contracts
10/18/2022
 
 
TXT CDRH Proposes 18 FY 2023 Guidances
10/18/2022
 
 
TXT Too Few Older Adults in Trials: Study
10/18/2022
 
 
TXT Changes Urged in ANDA Amendments Appendix
10/18/2022
 
 
TXT Califf Still Seeking Revamp of Accelerated Approval
10/18/2022
 
 
TXT Multiple Violations at Beijing Xinggu Lvsan
10/18/2022
 
 
TXT Draft Guide on Tissue Agnostic Drug Development
10/17/2022
 
 
TXT Guide on Immune-mediated Adverse Reactions
10/17/2022
 
 
TXT Medtronic Modifies Software for HeartWare Pump Problem
10/17/2022
 
 
TXT Guide on Acute Myeloid Leukemia Therapies
10/17/2022
 
 
TXT Review on Biogen Lou Gehrig’s Drug Extended
10/17/2022
 
 
TXT 2 Inspection Program Guides Revised
10/17/2022
 
 
TXT Guide on ANDA Prior Approval Supplements
10/14/2022
 
 
TXT Ulrich Medical 3D-printed Flux-C Cleared
10/14/2022
 
 
TXT ‘Missed Opportunity’ on FDA Reforms: Ex-Commissioners
10/14/2022
 
 
TXT Travere Expecting 3-month NDA Review Extension
10/14/2022
 
 
TXT Revive Therapeutics Amends Protocol on Covid Therapy
10/14/2022
 
 
TXT CMS Working with FDA on New Device Coverage Rule
10/13/2022
 
 
TXT FDA Revamping NDA/BLA Information Requests
10/13/2022
 
 
TXT Three Charged with Falsifying Clinical Trial Data
10/13/2022
 
 
TXT FDA Publishes ICH E19 Guideline
10/13/2022
 
 
TXT FDA Seeks Covis Info for Makena Hearing
10/13/2022
 
 
TXT GSK Respiratory Syncytial Virus Vaccine ‘Highly Efficacious’
10/13/2022
 
 
TXT FDA Says Adderall is in Shortage
10/13/2022
 
 
TXT CMC Comparability Protocol Guidance
10/13/2022
 
 
TXT Distributed Manufacturing Discussion Paper
10/13/2022
 
 
TXT OPDP Wants to Research Drug Name Interpretation
10/13/2022
 
 
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