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Panel Backs Rexulti for Alzheimer’s Agitation 04/17/2023

FDA Clears Reader for FreeStyle Libre 3 04/17/2023

Avenue Therapeutics Plans IV Tramadol Resubmission 04/17/2023

Complete Response on Lilly’s Ulcerative Colitis Drug 04/14/2023

High Court Issues 5-day Stay in Abortion Drug Case 04/14/2023

GOP Reps Challenge Generics from ‘Alert’ Firms 04/14/2023

2nd Complete Response on Alvotech Humira Biosimilar 04/14/2023

FDA Wants 2nd Study in Solgenix NDA 04/14/2023

Moximed Knee Shock Absorber Cleared 04/14/2023

Lupin Hit with 13-page 483 at India Plant 04/14/2023

PTA, Specialty Catheter Submission Guidance 04/13/2023

FDA ‘Rewrites’ History, Facts in Coreg Label Case: GSK 04/13/2023

FDA Accepts De Novo AlgoDx Sepis Detector 04/13/2023

FDA Clarifies Philips BiPAP, CPAP Replacement Numbers 04/13/2023

Government Turns to High Court in Mifepristone Appeal 04/13/2023

Guide on OTC Monograph Order Requests 04/13/2023

Panels to Consider Rexulti sNDA for Alzheimer’s Agitation 04/13/2023

Texas House Approves Drug Import Bill 04/13/2023

Pilot Program on Radiation Sterilization Master Files 04/12/2023

Format/Content of OTC Monograph Order Request 04/12/2023

Assessing Adhesion with Transdermal Systems 04/12/2023

Pragmatica-Lung Study Launches 04/12/2023

Omega Packaging CGMP Violations 04/12/2023

Class 3 Device Changes Up Recall Risk: Study 04/12/2023

Vanda Wants Teva Generic Hetlioz Pulled 04/12/2023

Transdermal Irritation/Sensitization Assessment 04/12/2023

Both Sides Argue Over Jurisdiction in Abortion Case 04/12/2023

Safety Alert on O&M N95 Respirators 04/12/2023

Clinical Trial Monitoring Q & A Guide 04/11/2023

Partial Hold on Molecular Templates Study 04/11/2023

Suggestions for Biosimilar Research Roadmap 04/11/2023

CGMP Issues at India’s Champaklal Pharmacy 04/11/2023

Improve ICH M13A Bioequivalence Guidance: PhRMA 04/11/2023

FDA Launching Patient Guidance Snapshots 04/11/2023

Health Misinformation Hurts Life Expectancy: Califf 04/11/2023

New FDA Cybersecurity Safeguard Requirements 04/11/2023

Companies Not Ready for New Cyber Safeguards: Article 04/11/2023

FDA Sets Device Radiation Sterilization File Pilot 04/11/2023

Regulatory Reforms Needed for AI Devices: Shuren 04/11/2023

Mifeprex Judge Damns FDA for Worse Abortion Outcomes 04/10/2023

What of FDA’s Gold Standard After Kacsmaryk? 04/10/2023

Panel to Mull Leqembi Confirmatory Study 04/10/2023

Sarepta Duchenne BLA Heads to Panel 04/10/2023

Reach Neuro Wins ‘Breakthrough’ for Stroke Stimulator 04/10/2023

DoJ Formally Appeals Mifepristone Texas Order 04/10/2023

Merck, Eisai Discontinue Melanoma Trial 04/10/2023

Horizon Therapeutics Touts Thyroid Eye Disease Data 04/10/2023

Phillips Recalls DreamStation Breathing Devices 04/07/2023

Two Imbruvica Accelerated Approvals Withdrawn 04/07/2023

Rep. Kim Reintroduces Drug Recall Authority Bill 04/07/2023

Florida Gets $600K in Cochlear Implants Case 04/07/2023

FDA Explores AI Image Analysis for Complex Drugs 04/07/2023

Boost Faith in Accelerated Approvals: Researchers 04/06/2023

RSVpreF Vaccine Meets Endpoints 04/06/2023

Mutagenic Impurities Guideline Adopted 04/06/2023

FDA Wants MDUFA 5 PPI Input 04/06/2023

FDA Pulls Makena Approval Immediately 04/06/2023

FDA Clears restor3D 510(k) for Ankle Device 04/06/2023

2 Texas Men Plead Guilty to Misbranded Drug Sales 04/06/2023

Endpoint Clinical Outcome Assessment Guidance 04/05/2023

3 Ex-Magellan Officials Charged Over Device Malfunctions 04/05/2023

Multiple Violations in Aspire Pharma Inspection 04/05/2023

Withdraw Wakix Approval: Scorpion Capital Petition 04/05/2023

Lab Tests Could be in Preparedness Bill 04/05/2023

QuVa Pharma FDA-483 04/05/2023

CDER is in Growth Mode from Hiring Spree: Cavazzoni 04/05/2023

OCP IND Prioritization, Triage Guidance 04/04/2023

Guide on Animal Drug Human Safety Assessments 04/04/2023

Abbott Safety Notice on FreeStyle Libre Readers 04/04/2023

Tavo-EP/Keytruda Fails Phase 2 Melanoma Trial 04/04/2023

Synovo Adulterated, Misbranded Products 04/04/2023

FDA ‘Consistent’ in Implementing NME Communications 04/04/2023

EUA for Gohibic for Some Hospitalized Covid Patients 04/04/2023

FDA on Pharmacodynamic Biomarker Research 04/04/2023

Docket Open for Opioids Home Disposal REMS 04/04/2023

FDA Selecting Fall Covid Vaccine Make-up in June 04/04/2023

BC3 Tech Clears SEAL Rapid Wound Spray 04/03/2023

Opioid Makers Must Provide Mail-back Envelope 04/03/2023

Untitled Letter to Minneapolis Regenerative Medicine 04/03/2023

Deficiencies Found in Ascendis Pharma NDA: FDA 04/03/2023

54% of Confirmatory Studies Are Late Meeting Deadlines 04/03/2023

Guide on Harmonized Medicinal Product Identification 03/31/2023

U.S. Government Sides with Generics in Labeling Case 03/31/2023

Datascope Recalls Cardiosave and Hybrid Pumps 03/31/2023

FDA Hits India Drug Maker with 14-page 483 03/31/2023

Bill Would Prevent ANDA Blocking on 1st Generics 03/31/2023

FDA Evaluating Adult Dental Device Concerns 03/30/2023

Midwest Vet Supply Forfeits $10 Million for Misbranding 03/30/2023

AI/ML Software Marketing Submission Guidance 03/30/2023

VALID Act Reintroduced 03/30/2023

Research on Some Child Subjects Guidance 03/30/2023

Align Global Gene, Cell Therapy Regulation: Marks 03/30/2023

FDA Converts 1 Keytruda Indication to Full Approval 03/30/2023

Califf Says GOP Budget Cuts Would Devastate FDA 03/30/2023

Device Cybersecurity Enforcement Discretion 03/29/2023

‘Objectionable Conditions’ in Med School Pediatric Trials 03/29/2023

AI/ML Proliferation Leading to Many Issues: Attorney 03/29/2023

FDA, Alliance Launch Lupus ABC 03/29/2023

Emergent Bio Gains OTC Approval of Narcan Spray 03/29/2023

FDA Shifting Accelerated Approval Approach: Attorneys 03/29/2023

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