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FDA-RELATED NEWS
 
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TXT U.S. Drug Shortages Increasing: Report
11/16/2023
 
 
TXT Provide Covid Therapeutics Distribution Info: Califf
11/16/2023
 
 
TXT Janet Woodcock Retiring in Early 2024
11/16/2023
 
 
TXT Managing Legacy Device Cyber Risks
11/16/2023
 
 
TXT Product Testing Alternative Methods
11/15/2023
 
 
TXT CGMP Violations in Turkish OTC Drug Manufacturer
11/15/2023
 
 
TXT FDA Punts Merck Cough Drug Data to Panel
11/15/2023
 
 
TXT Califf Backs Evidence Generation Report
11/15/2023
 
 
TXT Baxter Recalls Novum IQ Infusion Pump
11/15/2023
 
 
TXT Smart Women’s Choice Consent Decree
11/15/2023
 
 
TXT IceCure Medical Appeals De Novo Denial
11/15/2023
 
 
TXT QS Violations at Ming Fai Industrial
11/14/2023
 
 
TXT ‘Insanitary Conditions’ at India’s Global Pharma
11/14/2023
 
 
TXT Bayer Withdrawing Aliqopa After Failed Study
11/14/2023
 
 
TXT Former BD Exec Petitions FDA on Mesh Products
11/14/2023
 
 
TXT ODAC Looking at Long Delays in 2 Acrotech Trials
11/14/2023
 
 
TXT Comments on Cell & Gene Comparability Guide
11/14/2023
 
 
TXT Imfinzi Phase 3 Trial Fails
11/14/2023
 
 
TXT FDA Lawyer Nguyen Moves to Cooley
11/14/2023
 
 
TXT Congress Should Do More on Drug Shortages: Analysis
11/14/2023
 
 
TXT Improve Post-Market Evidence Generation: Report
11/14/2023
 
 
TXT Covidien Recalls Stolen Video Laryngoscopes
11/13/2023
 
 
TXT Republicans Threaten Subpoena on FDA Research
11/13/2023
 
 
TXT BridgeBio Filing NDA for Acoramidis
11/13/2023
 
 
TXT Data Support Wegovy Positive CV Outcomes
11/13/2023
 
 
TXT Exparel Gains Expanded Analgesic Use
11/13/2023
 
 
TXT Breakthrough Status for Brixton Coolio
11/13/2023
 
 
TXT Neurocrine Bio Stops 2 Develoment Programs
11/10/2023
 
 
TXT Consent Decree Against Drug Distributor
11/10/2023
 
 
TXT Covid Broke Vaccine Reporting System: BMJ
11/10/2023
 
 
TXT FDA De Novo for Owlet Dream Sock
11/10/2023
 
 
TXT Samsung Seeks Interchangeable Humira Biosimilar
11/10/2023
 
 
TXT CDER Quality Office Reorganizing Next Year
11/09/2023
 
 
TXT BD Mesh Products Alert on Breast Surgery
11/09/2023
 
 
TXT Brochure Overstates Phexxi Benefits: OPDP
11/09/2023
 
 
TXT FDA Updates Keytruda Gastric Cancer Indication
11/09/2023
 
 
TXT Blood Storage Container is Class 2
11/09/2023
 
 
TXT Takeda’s Adzynma Approved by FDA
11/09/2023
 
 
TXT Cyltezo Exclusivity End Dates Recommended
11/09/2023
 
 
TXT FDA Approves Recor Paradise System
11/08/2023
 
 
TXT Don’t Approve Amryt’s Filsuvez NDA: Petition
11/08/2023
 
 
TXT Former Reviewer McGarry Joins Greenleaf Health
11/08/2023
 
 
TXT Rexulti Ads ‘False and Misleading’: OPDP
11/08/2023
 
 
TXT Lilly Obesity Drug Gains FDA Approval
11/08/2023
 
 
TXT Support for Convalescent Plasma Registries
11/08/2023
 
 
TXT Democrats Introduce Anti Pay-for-Delay Bill
11/08/2023
 
 
TXT Guide on Real-Time Oncology Reviews
11/08/2023
 
 
TXT 14 Observations in Kilitch India FDA-483
11/07/2023
 
 
TXT Improve Cell, Gene Manufacturing Guidance: ISCT
11/07/2023
 
 
TXT FTC Challenges Patent Listings in Orange Book
11/07/2023
 
 
TXT Law Blog Faults FDA on Remote ‘Evaluations’
11/07/2023
 
 
TXT Neurotris Illegally Marketing Devices: FDA
11/07/2023
 
 
TXT Real-Time Oncology Review Guidance
11/07/2023
 
 
TXT Bill Seeks to Shift Drug Making to U.S.
11/07/2023
 
 
TXT Covid Container Closure Guidance Still Effective
11/07/2023
 
 
TXT J&J Plans 2024 Surgery Robot IDE Trials
11/07/2023
 
 
TXT One-Third of BTD Requests Granted: Analysis
11/07/2023
 
 
TXT Orphan Status for Breast Cancer Radiotherapy
11/06/2023
 
 
TXT Guide on ‘Item Response Theory’ Clinical Data
11/06/2023
 
 
TXT Guide on Device Export Certifications
11/06/2023
 
 
TXT CDRH Endorses Device Cybersecurity Standard
11/06/2023
 
 
TXT Petition Seeks to Block Vigabatrin Exclusivity
11/06/2023
 
 
TXT Submitting PRO Data in Cancer Trials Guide
11/03/2023
 
 
TXT House Oversight Panel Probes Drug Shortages
11/03/2023
 
 
TXT Supernus Parkinson’s Off Episodes NDA Refiled
11/03/2023
 
 
TXT Empatica Adds 2 Biomarkers to Monitoring Device
11/03/2023
 
 
TXT FDA/Moderna ‘Revolving Door’ Analyzed
11/02/2023
 
 
TXT Lilly Sees Alzheimer’s Drug Decision Delay
11/02/2023
 
 
TXT Fix Pulse Oximeter Biases, 25 State AGs Tell FDA
11/02/2023
 
 
TXT FDA Seeking Diabetes DHT Info
11/02/2023
 
 
TXT FDA OKs Abbott HPV Diagnostic Test
11/02/2023
 
 
TXT Monoclonal Antibody Manufacturing Changes Research
11/02/2023
 
 
TXT I-Mab Gets Breakthrough for Nephropathy
11/02/2023
 
 
TXT House GOPers ‘Concerned’ About FDA Lab Safety
11/02/2023
 
 
TXT FDA Continues Device Supplement Guidance
11/01/2023
 
 
TXT Why Are FDA-483 Observations the Same?
11/01/2023
 
 
TXT Panel Backs Sickle Cell Gene Therapy Safety
11/01/2023
 
 
TXT FDA Expects Increasing Cannabis Research
11/01/2023
 
 
TXT Unlicensed Wholesaler Sentenced to Prison
11/01/2023
 
 
TXT Tonix Shuts Down Depression Drug Development
11/01/2023
 
 
TXT New FDA Off-Label Guide Has ‘Challenges’: Lawyers
11/01/2023
 
 
TXT FDA Sends 8-item 483 to NATCO Pharma
11/01/2023
 
 
TXT Multiple Violations at WAVi Co.
10/31/2023
 
 
TXT Stakeholders’ Views on FRAME
10/31/2023
 
 
TXT Clinical Hold Lifted on Mersana’s XMT-2056
10/31/2023
 
 
TXT Changes Sought to FDA’s IT Strategy
10/31/2023
 
 
TXT API CGMP Deviations at Ali Pharmaceutical
10/31/2023
 
 
TXT ‘Objectionable Conditions’ at BTS Research
10/31/2023
 
 
TXT FDA OKs Gene Therapy Trial for Heart Disease
10/31/2023
 
 
TXT AdvaMed Points ONCD to Cyber Harmonization
10/31/2023
 
 
TXT Amgen’s Interchangeable Stelara Biosimilar Approved
10/31/2023
 
 
TXT FDA Should Develop Vision PRO Tool: AdvaMed
10/30/2023
 
 
TXT FDA Warns on 26 Eye Drop Products
10/30/2023
 
 
TXT Sarepta Seeking Gene Therapy Expanded Use
10/30/2023
 
 
TXT GSK Jemperli Trial Meets Endpoint
10/30/2023
 
 
TXT Novartis Seeks Accelerated OK for IgAN Drug
10/30/2023
 
 
TXT Lilly’s Ulcerative Colitis Therapy Approved
10/27/2023
 
 
TXT TX Man Gets 5 Years Over Unapproved Drugs
10/27/2023
 
 
TXT Sickle Cell Therapy Safety Assessment Questioned
10/27/2023
 
 
TXT Bill to Reduce Dependence on China Drugs
10/27/2023
 
 
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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:
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