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New AI Transparency Minimums Needed: Column 01/10/2023

FDA, Health Canada Open eSTAR Pilot 01/10/2023

AdvaMed Recommendations on Consensus Standards 01/10/2023

NDA/BLA Approval Metrics Take a Hit in 2022 01/10/2023

CDER Dismisses 26% Drop in 2022 Drug Approvals 01/09/2023

BioMarin Filing Additional Data for Hemophilia Gene Therapy 01/09/2023

Troubled Zyno Pays $493K over False Claims 01/09/2023

Review extension for Krystal Gene Therapy BLA 01/09/2023

CardiacSense Vital Signs Watch Cleared by FDA 01/09/2023

Law Extends Product Info Sharing Safe Harbor to Devices 01/06/2023

Evusheld May Not Neutralize New Covid Variant: FDA 01/06/2023

FDA Hits Ipsen with Complete Response on Palovarotene 01/06/2023

Generic Drug Controlled Correspondence Revised Guidance 01/06/2023

ODT Launches Leadership Modernization Action Plan 01/06/2023

FDA Delays Toripalimab PDUFA Action Date 01/06/2023

Cavazzoni Tries to Repair Credibility with New Alzheimer’s OK 01/06/2023

Lupin Recalls 4 Quinapril Lots 01/05/2023

FDA Approves Zycosan for Horses with Osteoarthritis 01/05/2023

Reverse ‘Calif. Consumer Protection Regime’: WLF 01/05/2023

Genentech’s Lunsumio OK’d for Some Lymphomas 01/05/2023

REMS Document Technical Conformance Guide 01/05/2023

Jet Medical, Other Companies, Pay $700,000 in Device Cases 01/05/2023

Checkpoint Therapeutics BLA for Skin Cancer 01/05/2023

5 Observations on Glenmark FDA-483 01/05/2023

FDA Approves Rozlytrek Companion Diagnostic 01/05/2023

Group Urges Postponement of Alzheimer’s Drug Decision 01/05/2023

Build Flexibility into Pubertal Development Guidance: BIO 01/05/2023

AstraZeneca BLA for RSV Prevention in Infants 01/05/2023

Medical Device Consensus Standards Database Updated 01/04/2023

FDA Changes Mifepristone REMS 01/04/2023

FDA Reforms Included in Year-end Omnibus Bill 01/04/2023

Accord Healthcare Recalls 2 Daptomycin Products 01/04/2023

FDA Approves Acer’s Olpruva for Urea Cycle Disorders 01/04/2023

RoyalVibe Health Refused Inspection: FDA 01/04/2023

Inspection Issues at Sagent’s Plattsburgh Facility 01/04/2023

FTC Updates Health Products Compliance Guide 01/04/2023

CGMP Deviations Found at MD Pharmaceutical Supply 01/04/2023

FDA Delays PDUFA Action Date for Phathom’s Vonoprazan 01/04/2023

New Alzheimer’s Drug OK This Week Won’t Do Much for Patients: Article 01/04/2023

REMS Document Format, Content Guidance 01/04/2023

Arrow Intra-Aortic Balloon Pump Recall is Class 1 01/04/2023

Latest Potential Signals of Serious Drug Risks 01/04/2023

Drug Companies Expected to Hike Prices 01/04/2023

Vivos Gets Sleep Apnea Device Cleared 01/04/2023

Consider Oncology Single-Arm Trial Issues: CDER 01/04/2023

FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study 01/04/2023

Advanced Bionics Paying $12 Million Over False Claims 01/03/2023

CGMP Deviations at Brazil’s Nortec Quimica 01/03/2023

FDA States Plan B One-Step Does Not Cause an Abortion 01/03/2023

Court Enters Consent Decree Against Oklahoma Compounder 01/03/2023

M11 Clinical Electronic Structured Protocol 01/03/2023

Drug Risks and Benefits in CSL Communications 01/03/2023

‘Objectionable Conditions’ at Clinical Investigation Site 01/03/2023

Spending Bill Reverses Some FDA Court Losses: Attorneys 01/03/2023

FDA Pushing Naloxone OTC Switch: Attorney 01/03/2023

Hypertension Labeling for Cardio Claims Guidance 01/03/2023

FDA Gets $226 Million Spending Boost in Budget Bill 01/03/2023

FDA Grants Ardelyx’ Xphozah Appeal 01/03/2023

FDA Discusses 2 New Trilogy Ventilator Issues 01/03/2023

FDA Needs More Global Help Against Crime: Hermsen 01/03/2023

Reactions to Aduhelm Report Blast FDA Closeness to Industry 01/03/2023

Providence Medical Tech Cavux Facet Device Cleared 12/16/2022

FDA OK’s Ferring’s Bladder Cancer Gene Therapy 12/16/2022

Panel to Examine Ongoing Covid Vaccine Modifications 12/16/2022

Contractor Conflict-of Interest Bill Passes Congress 12/16/2022

Aurigene Ditches Psoriasis Drug Candidate 12/16/2022

FDA Updates CRL Guidance Performance Goals 12/15/2022

Comments on Immune-Mediated Adverse Reaction Guidance 12/15/2022

Independent FDA Needed to Stop Political Meddling: GAO 12/15/2022

Draft Guide on Pulmonary Tuberculosis Drugs 12/15/2022

Draft Inspection Refusal Guidance 12/15/2022

FDA Stem Cell Therapy Regulation at Risk: Attorneys 12/15/2022

States Pushing for Canadian Drug Imports: Report 12/14/2022

Harmonize Innovative Manufacturing Regulation: PhRMA 12/14/2022

AdvaMed Supports Breakthrough Device Guidance Updates 12/14/2022

VALID Could Hurt Home Sample Testing: Attorneys 12/14/2022

Former NECC Ops Director Sentenced to 5 Months in Jail 12/14/2022

FDA Panel Thumbs Down on Heart Failure Drug 12/14/2022

FDA Accepts NDA for Eye Dilating Combo Product 12/13/2022

$2.25 mil. RWD Funding Opportunity 12/13/2022

CGMP Deviations Seen in Centrient Inspection 12/13/2022

Clinicians Need Refresher on Clinical Trial Statistics: Survey 12/13/2022

What’s Behind the New LASIK Guidance? 12/13/2022

Assign TE Codes for All Approved Drugs: Study 12/13/2022

Change Antibiotic Development Incentives: Study 12/13/2022

Moderna/Merck Cancer Vaccine Meets Endpoint 12/13/2022

Doc Group Wants FDA Probe of Musk’s Neuralink 12/13/2022

Smiths Device Correction on CADD Infusion System 12/12/2022

CVM Sees 1% Decrease in Food Animal Antimicrobial Use 12/12/2022

Academics Urge FDA to Simplify Breast Density Notifications 12/12/2022

DoJ Indictment on Unapproved Drugs 12/12/2022

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program 12/12/2022

FDA Hits 2 QuVA Pharma Facilities with 483s 12/12/2022

Green Pharmaceuticals’ SnoreStop ‘Adulterated’: FDA 12/11/2022

Empowered Diagnostics Unapproved Covid Tests 12/11/2022

FDA Will Review Pfizer Etrasimod NDA 12/11/2022

Address Prescription Adderall Shortage: Spanberger 12/11/2022

Academics Urge Tougher FDA Stance on Accelerated NDAs 12/09/2022

Device Voluntary Malfunction Summary Reporting Guide 12/09/2022

Remel Recalls Thermo Scientific Sensititre Plates 12/09/2022

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