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FDA-RELATED NEWS
 
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TXT Include all Media in Drug Promotion Regs: Professors
01/26/2023
 
 
TXT Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions
01/25/2023
 
 
TXT Final Guide on Compounding Ibuprofen Suspensions
01/25/2023
 
 
TXT Cardiosave Intra-Aortic Balloon Pumps Recalled
01/25/2023
 
 
TXT Improving Myelodysplastic Syndromes Trials
01/25/2023
 
 
TXT FDA Lifts Hold on Inhibikase Parkinson’s Trial
01/25/2023
 
 
TXT BsUFA Regulatory Research Roadmap
01/25/2023
 
 
TXT FDA/Aetion Oncology RWD Research
01/25/2023
 
 
TXT GenBioPro Sues to Overturn WV Abortion Pill Law
01/25/2023
 
 
TXT Merck Ending Keytruda Phase 3 Prostate Cancer Trial
01/25/2023
 
 
TXT Panel Votes to Approve Cidara’s Rezafungin
01/25/2023
 
 
TXT ‘7 Deadly Sins’ at FDA Presentations: Mikkael Sekeres
01/24/2023
 
 
TXT Biogen’s Lou Gehrig’s NDA Heads to Panel Review
01/24/2023
 
 
TXT AdvaMed Device Sterilization Reg Proposals for EPA
01/24/2023
 
 
TXT Lobbying Killed VALID Act: ProPublica
01/24/2023
 
 
TXT Many Advertised Drugs Have Low Therapeutic Value: Study
01/24/2023
 
 
TXT ‘Objectionable Conditions’ in Larkin Hospital IRB
01/24/2023
 
 
TXT ‘Corrective Recall’ Asked for Hemodialysis Units
01/24/2023
 
 
TXT 2022 FDA Advertising, Promotion Enforcement Reviewed
01/24/2023
 
 
TXT FDA Backs Status Quo in Orphan Drug Exclusivity
01/23/2023
 
 
TXT FDA Moving to Annual Covid Strain Selection Like Flu
01/23/2023
 
 
TXT FDA Releases Cannabis Clinical Research Guidance
01/23/2023
 
 
TXT DePuy Synthes Pays $10 Million to Settle Kickback Scheme
01/23/2023
 
 
TXT Petition Urges FDA to Regulate LED-pulsing Devices
01/23/2023
 
 
TXT Advertising Group Hits Novartis on Kisqali DTC Ad
01/23/2023
 
 
TXT Guidance on Ibuprofen Compounding to Help Shortages: FDA
01/20/2023
 
 
TXT FDA Memo Recommends Califf Order Makena’s Withdrawal
01/20/2023
 
 
TXT Medtronic Recalls Extended to More HeartWare Batteries
01/20/2023
 
 
TXT Panel to Discuss Opioid Postmarketing Requirement
01/20/2023
 
 
TXT FDA Lifts Clinical Hold on Pompe Gene Therapy
01/20/2023
 
 
TXT ICH Quality Risk Management Guide Adopted by FDA
01/20/2023
 
 
TXT Mend Lax Clinical Trial Reporting: Pallone
01/19/2023
 
 
TXT FDA Denies Fresenius Glycopyrrolate Petition
01/19/2023
 
 
TXT Contrast Agent, Radioactive Drug, OTC Drug Status Clarified
01/19/2023
 
 
TXT Conformity Assessment Program Information Collection
01/19/2023
 
 
TXT Surmodics SurVeil PMA ‘Not Approvable’: FDA
01/19/2023
 
 
TXT FDA Amends, Repeals Some Rad Health Regs
01/19/2023
 
 
TXT FDA Seeks Injunction Against LGM Pharma
01/19/2023
 
 
TXT 11 Observations on Intas Pharmaceuticals FDA-483
01/19/2023
 
 
TXT Realize Medical Virtual Reality Surgical Tool Cleared
01/19/2023
 
 
TXT Fix the Evidence Generation System Now: Califf
01/19/2023
 
 
TXT FDA Wants RWD User Fee Funding Comments
01/18/2023
 
 
TXT Janssen Ending Mosaico HIV Vaccine Trial
01/18/2023
 
 
TXT Deny Mifepristone Preliminary Injunction: FDA
01/18/2023
 
 
TXT Moderna to Seek RSV Vaccine OK
01/18/2023
 
 
TXT Improve HHS Oversight of Pathogen Research: GAO
01/18/2023
 
 
TXT CDER Continuing QMM Program Development
01/18/2023
 
 
TXT Stakeholder Suggestions for IHC Q5A Guidance
01/18/2023
 
 
TXT FDA Denies Petition on Gabapentin Scheduling
01/18/2023
 
 
TXT Sterile Drug Issues at Optum Infusion
01/17/2023
 
 
TXT FDA Expands CN Bio Collaboration
01/17/2023
 
 
TXT Diagnostics, Dietary Supplement Reforms on FDA Legislative Agenda
01/17/2023
 
 
TXT Guide Seeks Dose Optimization in Cancer Drug Development
01/17/2023
 
 
TXT Improve FDA Management of IT Contracts: OIG
01/17/2023
 
 
TXT BsUFA 3 Changes Described
01/17/2023
 
 
TXT Woman Sentenced in Drug Trial False Statement Case
01/17/2023
 
 
TXT Appeals Court Nixes Sandoz Generic Aubagio Suit
01/17/2023
 
 
TXT AstraZeneca Discontinuing Lumoxiti for Hairy Cell Leukemia
01/13/2023
 
 
TXT FDA/CDC Dismiss ‘Signal’ with Pfizer Bivalent Vaccine
01/13/2023
 
 
TXT Coviden Recalls Mahurkar Dialysis Catheter
01/13/2023
 
 
TXT Novo Nordisk’s Rebelsus Now OK for 1st Line Use
01/13/2023
 
 
TXT 5 Observations in Alembic FDA Inspection
01/12/2023
 
 
TXT Stop Trying to Prevent Covid in Healthy People: Offit
01/12/2023
 
 
TXT Dosage and Administration Label Section Guidance
01/12/2023
 
 
TXT ‘Minor Updates’ to 2 Covid Test Guidances
01/12/2023
 
 
TXT Oramed Shelves Diabetes Drug After Phase 3 Miss
01/12/2023
 
 
TXT Swiss-FDA Mutual Recognition Agreement
01/12/2023
 
 
TXT Implementing Cybersecurity Provision in Spending Bill
01/12/2023
 
 
TXT NCVHS Should Add UDIs to Claims Forms: Article
01/12/2023
 
 
TXT Physicians Seek Panel Review for ‘Full Approval’ of Alzheimer’s Drug
01/12/2023
 
 
TXT Many Recalled 510(k) Devices Had Recalled Predicates: Study
01/11/2023
 
 
TXT Attorneys Look Back, Ahead at FDA
01/11/2023
 
 
TXT 2 Olympus Endoscope Warning Letters
01/11/2023
 
 
TXT PhRMA Expresses ICH Q12 Guidance Concerns
01/11/2023
 
 
TXT Vaccine Advisors Angry at Lack of Transparency
01/11/2023
 
 
TXT We Agree: FDA Should Jettison Foods
01/11/2023
 
 
TXT Criminal Probe Nets 2 Guilty Pleas Over Stolen Test Strips
01/11/2023
 
 
TXT New AI Transparency Minimums Needed: Column
01/10/2023
 
 
TXT FDA, Health Canada Open eSTAR Pilot
01/10/2023
 
 
TXT AdvaMed Recommendations on Consensus Standards
01/10/2023
 
 
TXT NDA/BLA Approval Metrics Take a Hit in 2022
01/10/2023
 
 
TXT CGMP Violations at India’s Sun Pharmaceutical
01/10/2023
 
 
TXT Standardizing REMS Information in SPL
01/10/2023
 
 
TXT CDER Dismisses 26% Drop in 2022 Drug Approvals
01/09/2023
 
 
TXT BioMarin Filing Additional Data for Hemophilia Gene Therapy
01/09/2023
 
 
TXT Troubled Zyno Pays $493K over False Claims
01/09/2023
 
 
TXT Review extension for Krystal Gene Therapy BLA
01/09/2023
 
 
TXT CardiacSense Vital Signs Watch Cleared by FDA
01/09/2023
 
 
TXT Cavazzoni Tries to Repair Credibility with New Alzheimer’s OK
01/06/2023
 
 
TXT FDA Hits Ipsen with Complete Response on Palovarotene
01/06/2023
 
 
TXT Law Extends Product Info Sharing Safe Harbor to Devices
01/06/2023
 
 
TXT Evusheld May Not Neutralize New Covid Variant: FDA
01/06/2023
 
 
TXT Generic Drug Controlled Correspondence Revised Guidance
01/06/2023
 
 
TXT ODT Launches Leadership Modernization Action Plan
01/06/2023
 
 
TXT FDA Delays Toripalimab PDUFA Action Date
01/06/2023
 
 
TXT 5 Observations on Glenmark FDA-483
01/05/2023
 
 
TXT FDA Approves Rozlytrek Companion Diagnostic
01/05/2023
 
 
TXT Group Urges Postponement of Alzheimer’s Drug Decision
01/05/2023
 
 
TXT Build Flexibility into Pubertal Development Guidance: BIO
01/05/2023
 
 
TXT AstraZeneca BLA for RSV Prevention in Infants
01/05/2023
 
 
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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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