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FDA-RELATED NEWS
 
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TXT UCB on Pregnancy Safety Studies
11/30/2023
 
 
TXT FDA Clears GE Critical Care Suite 2.1
11/30/2023
 
 
TXT FDA Fast Track for eFFECTOR’s Zotatifin
11/30/2023
 
 
TXT AdvaMed Comments on Electronic Submission Guide
11/29/2023
 
 
TXT Concerns About FDA QMM Program
11/29/2023
 
 
TXT Durbin, Grassley Push Drug Ad Transparency Bill
11/29/2023
 
 
TXT FDA Opens Drug Supply Chain Security Act Portal
11/29/2023
 
 
TXT FDA Denies Apixaban ANDA Petition for Safety
11/29/2023
 
 
TXT SCA Pharma Issued 10-Item FDA-483
11/29/2023
 
 
TXT Karuna NDA for Schizophrenia Accepted by FDA
11/29/2023
 
 
TXT Praise for Graft-Versus-Host Drug Guidance
11/29/2023
 
 
TXT FDA Studies Nasal Spray Distribution
11/29/2023
 
 
TXT FDA Still Evaluating Left Atrial Occlusion Implants
11/29/2023
 
 
TXT New Theories of False Claims Act Liability
11/29/2023
 
 
TXT Regenerative Medicine Consensus Standards Guide
11/28/2023
 
 
TXT ‘Similar’ Intas CGMP Violations
11/28/2023
 
 
TXT Korsuva Regulatory Review Period
11/28/2023
 
 
TXT Cosela Regulatory Review Period
11/28/2023
 
 
TXT Serious Reaction to Some Anti-Seizure Meds: FDA
11/28/2023
 
 
TXT Acelyrin Auditing Izokibep Trial Issues
11/28/2023
 
 
TXT Dr. Berne’s Selling Unapproved, Adulterated Eye Drops
11/28/2023
 
 
TXT Malignancy Events with CAR T-Cell Therapies: FDA
11/28/2023
 
 
TXT FDA Warns on Overheating Philips CPAP Devices
11/28/2023
 
 
TXT Biden to use Defense Production Act on Shortages
11/28/2023
 
 
TXT ‘Mixed Reality Device’ CGMP Inspection Success
11/28/2023
 
 
TXT FDA Withdraws From Device Harmonization Group
11/27/2023
 
 
TXT Priority Review for Abeona Therapeutics BLA
11/27/2023
 
 
TXT Aldeyra Complete Response on Dry Eye NDA
11/27/2023
 
 
TXT Novartis Recalls 2 Sandimmune Lots
11/27/2023
 
 
TXT VAERS Has ‘A Proven Track Record’: FDA/CDC
11/22/2023
 
 
TXT SCOTUS Should Hear Mifepristone Appeal: FDA
11/22/2023
 
 
TXT Entrada Therapeutics’ DMD Drug Remains on Hold
11/22/2023
 
 
TXT Covid-19 Treatment, Prevention Products Guidance
11/22/2023
 
 
TXT Guide on GLP Study Translation
11/22/2023
 
 
TXT FDA Declines to Ban Some Music in DTC Ads
11/22/2023
 
 
TXT Masimo Medical Watch Cleared by FDA
11/22/2023
 
 
TXT Chinese National Indicted Over Illegal Devices
11/21/2023
 
 
TXT GLP Report Translation Q&A Guidance
11/21/2023
 
 
TXT Concerns Over FDA Biosimilar Labeling Draft Guide
11/21/2023
 
 
TXT Repeat CGMP Violations at Cipla Plant
11/21/2023
 
 
TXT Study New Guide on Science Info for MDs: Attorneys
11/21/2023
 
 
TXT ‘Objectionable Conditions’ in 2 Clinical Trials
11/21/2023
 
 
TXT Do Postmarket Studies Need Public Funds?: Califf
11/21/2023
 
 
TXT Senators Want Animal Testing Info
11/21/2023
 
 
TXT Medtronic’s Symplicity for Hypertension Approved
11/20/2023
 
 
TXT Abecma Review Delayed for Panel Input
11/20/2023
 
 
TXT Info Sought on Supply Chain Security
11/20/2023
 
 
TXT Final Rule on DTC Ads’ Major Statements
11/20/2023
 
 
TXT Bayer Stops Stroke Drug Study Over Inferiority
11/20/2023
 
 
TXT FDA Warns on Monoject Syringes
11/20/2023
 
 
TXT Janssen Seeks Expanded Rybrevant Use
11/20/2023
 
 
TXT Dr. Reddy’s Issued 10-item FDA-483
11/17/2023
 
 
TXT FDA OKs AstraZeneca Breast Cancer Drug
11/17/2023
 
 
TXT Merck’s Keytruda Gains OK in Gastric Cancer
11/17/2023
 
 
TXT Asensus Surgical Recalls Robot Devices
11/17/2023
 
 
TXT FDA OK’s Ferring’s Bladder Cancer Gene Therapy
12/16/2022
 
 
TXT Panel to Examine Ongoing Covid Vaccine Modifications
12/16/2022
 
 
TXT Contractor Conflict-of Interest Bill Passes Congress
12/16/2022
 
 
TXT Aurigene Ditches Psoriasis Drug Candidate
12/16/2022
 
 
TXT Providence Medical Tech Cavux Facet Device Cleared
12/16/2022
 
 
TXT Draft Guide on Pulmonary Tuberculosis Drugs
12/15/2022
 
 
TXT Draft Inspection Refusal Guidance
12/15/2022
 
 
TXT FDA Stem Cell Therapy Regulation at Risk: Attorneys
12/15/2022
 
 
TXT FDA Updates CRL Guidance Performance Goals
12/15/2022
 
 
TXT Comments on Immune-Mediated Adverse Reaction Guidance
12/15/2022
 
 
TXT Independent FDA Needed to Stop Political Meddling: GAO
12/15/2022
 
 
TXT Harmonize Innovative Manufacturing Regulation: PhRMA
12/14/2022
 
 
TXT AdvaMed Supports Breakthrough Device Guidance Updates
12/14/2022
 
 
TXT VALID Could Hurt Home Sample Testing: Attorneys
12/14/2022
 
 
TXT Former NECC Ops Director Sentenced to 5 Months in Jail
12/14/2022
 
 
TXT FDA Panel Thumbs Down on Heart Failure Drug
12/14/2022
 
 
TXT States Pushing for Canadian Drug Imports: Report
12/14/2022
 
 
TXT FDA Accepts NDA for Eye Dilating Combo Product
12/13/2022
 
 
TXT $2.25 mil. RWD Funding Opportunity
12/13/2022
 
 
TXT CGMP Deviations Seen in Centrient Inspection
12/13/2022
 
 
TXT Clinicians Need Refresher on Clinical Trial Statistics: Survey
12/13/2022
 
 
TXT What’s Behind the New LASIK Guidance?
12/13/2022
 
 
TXT Assign TE Codes for All Approved Drugs: Study
12/13/2022
 
 
TXT Change Antibiotic Development Incentives: Study
12/13/2022
 
 
TXT Moderna/Merck Cancer Vaccine Meets Endpoint
12/13/2022
 
 
TXT Doc Group Wants FDA Probe of Musk’s Neuralink
12/13/2022
 
 
TXT Smiths Device Correction on CADD Infusion System
12/12/2022
 
 
TXT CVM Sees 1% Decrease in Food Animal Antimicrobial Use
12/12/2022
 
 
TXT Academics Urge FDA to Simplify Breast Density Notifications
12/12/2022
 
 
TXT DoJ Indictment on Unapproved Drugs
12/12/2022
 
 
TXT Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program
12/12/2022
 
 
TXT FDA Hits 2 QuVA Pharma Facilities with 483s
12/12/2022
 
 
TXT Academics Urge Tougher FDA Stance on Accelerated NDAs
12/09/2022
 
 
TXT Device Voluntary Malfunction Summary Reporting Guide
12/09/2022
 
 
TXT Remel Recalls Thermo Scientific Sensititre Plates
12/09/2022
 
 
TXT Janssen Files BLA for Myeloma Therapy
12/09/2022
 
 
TXT 2 Roche Alzheimer’s Tests Cleared by FDA
12/09/2022
 
 
TXT 10 Observations in Aurobindo Unit FDA-483
12/08/2022
 
 
TXT Non-Device Software Function Report
12/08/2022
 
 
TXT Draft VMSR Guidance for Manufacturers
12/08/2022
 
 
TXT 16 Observations on Lupin Unit FDA-483
12/08/2022
 
 
TXT FDA Proposes More Comprehensive IND Reports
12/08/2022
 
 
TXT Draft Device Human Factors Guidance
12/08/2022
 
 
TXT Comments on Pediatric Clinical Pharmacology Draft
12/08/2022
 
 
TXT FDA Manuscript in the Works on Trial Diversity Strategy
12/08/2022
 
 
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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:
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