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Novartis Gets Another Facility OK’d for Pluvicto 04/21/2023

DTC Research Raises Concern on Endpoints in Cancer Ads 04/21/2023

10 Observations in Lupin FDA-483 04/20/2023

Sarepta Comments on Golodirsen PSG 04/20/2023

GE Healthcare’s Carescape Patient Monitor Cleared 04/20/2023

FDA Describes New QSAR Model 04/20/2023

FDA Failed to Collect $45 bil. Drug Trial Fines: Students 04/20/2023

Califf Testifies on Accelerated Approvals 04/20/2023

BelGene Gastric Cancer Drug Trial Hits Primary Endpoint 04/20/2023

CGMP Violations at Zermat International 04/19/2023

Fresenius Kabi Recalls Ivenix Infusion Device 04/19/2023

North American Diagnostics Illegal Covid Tests 04/19/2023

Radiation Syndrome Drug Development Guidance 04/19/2023

NCI Sees Revumenib Promise for Some Leukemias 04/19/2023

FDA Cautions Compounders on Bulk Sources 04/19/2023

FDA Drug Inspections Slow to Recover: Analysis 04/19/2023

Guidance Shows Importance of Sponsor Oversight: Attorneys 04/19/2023

Generic Mifepristone Maker Sues FDA 04/19/2023

High Court Adds 2 Days to Mifepristone Stay 04/19/2023

EMA/FDA Bioequivalence Info Sharing Pact Adds Ireland 04/19/2023

FDA OKs 2nd Covid Booster for Some People 04/18/2023

Lessons Learned from Rare Disease Trials During Covid 04/18/2023

OND Expands Regulatory Science Research 04/18/2023

Intarcia Raises NDA Advisory Committee Issues 04/18/2023

House Oversight Panel Puts Heat on FDA Over CBD 04/18/2023

Research Describes Drug Ad Data Display 04/18/2023

Royal Chemical Inspection Finds CGMP Violations 04/18/2023

Multiple Abbott i-STAT Test Violations 04/18/2023

Workshop on Rare Disease Endoints 04/17/2023

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

GSK Plans NDA for Antibiotic Gepotidacin 04/17/2023

FDA ‘Top Cop’ McMeekin Retiring 6/30, Then Many More 04/17/2023

Gamida Cell Therapy Approved by FDA 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

FDA on Pharmacodynamic Biomarker Research 04/04/2023

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

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