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SD Biosensor Recalls Contaminated Covid Tests 05/24/2023

Call Out Lawyer Client-Seeking Ads: Petition 05/24/2023

Ex-FDAer Schiller on Accelerated Approval Guide 05/23/2023

Melanoma Imaging Device Get Breakthrough Status 05/23/2023

Lawyer’s Motion to Remain Anonymous Granted 05/23/2023

FDA OK’s New Opioid Use Disorder Option 05/23/2023

Abbott Touts Data on Dual Chamber Pacemaker 05/23/2023

FDA Approval Reciprocity Bill Reintroduced 05/23/2023

FDA Denies Petition for PPI Pneumonia Warning 05/23/2023

Contract Testing Lab Gets Warning Letter 05/23/2023

New FDA MOU for Distributed Manufacturing 05/23/2023

Figures in Tellus Clinical Trial Fraud Case Acquitted 05/23/2023

Petition for Warning on Diabetes Drugs Denied 05/22/2023

CDRH Portal Expanded to Pre-Submission Feedback 05/22/2023

Novo Nordisk Plans NDA for Oral Obesity Drug 05/22/2023

Rain Oncology Scraps Milademetan 05/22/2023

FDA OKs Opiant Pharma’s Opioid Overdose Spray 05/22/2023

FDA Issues 483 to Aurobindo API Facility 05/19/2023

DTC Research Supports Disclosures on Endpoint Differentiation 05/19/2023

Abiomed Recalls Impella 5.5. Blood Pump 05/19/2023

Zoll Settles Case Against China-made ECG Cables 05/19/2023

Topical Gene Therapy for Wounds Approved 05/19/2023

‘Bionic Pancreas’ Cleared by FDA 05/19/2023

Revoke Approval for MSN’s Generic Hetlioz: Vanda 05/18/2023

Nephron Pharmaceuticals Warehouse FDA-483 05/18/2023

AbbVie Gets Rinvoq OK for Crohn’s 05/18/2023

Draeger Recalls Seattle CPAP Device and Components 05/18/2023

Child Cancer Research Bill Reintroduced 05/18/2023

House Dems Working on Cancer Drug Shortage 05/18/2023

Appropriators Cut FDA Budget by $600 million 05/18/2023

Panel Backs Pfizer’s RSV Vaccine 05/18/2023

2 Pediatric Drug Approval Guidances 05/17/2023

ICU Medical Recalls Pumps Over Battery Defect 05/17/2023

Device Panel to Tackle Health Equity 05/17/2023

Reviewers Question Intercept’s Liver Drug 05/17/2023

Bill to Use Industry Penalties for Cancer Research 05/17/2023

Califf Hopeful on Alzheimer’s, Obesity Drug Data 05/17/2023

Drug Company Patent Violations Cost $40 Billion: Study 05/17/2023

Reject Apotex Generic Fintepla ANDA: UCB 05/17/2023

Prothena Adds Ex-FDA Neuroscience Head to Board 05/17/2023

Attorney Sues FDA to Keep Name Off FDA-483 05/17/2023

Pharmedica CGMP Violations Result in Plant Shutdown 05/16/2023

Ipca Laboratories FDA-483 05/16/2023

FDA Issues with Sea-Long Medical Treatment Hoods 05/16/2023

Bespoke Gene Therapy Portfolio has 8 Diseases 05/16/2023

Let Compounders Help with Drug Shortages: Op-Ed 05/16/2023

Did Recarbrio Approval Break FDA Rules? 05/16/2023

Judge Hits Precision Lens with $487 Million Fine 05/16/2023

Abbott Spinal Stimulation Devices OK for Back Pain 05/16/2023

Comments on Electronic Systems Q&A Draft 05/16/2023

Byondis BLA on Breast Cancer Therapy Rejected 05/15/2023

Supreme Court Turns Down Skinny Label Case 05/15/2023

Split Vote on Sarepta Gene Therapy 05/15/2023

Pedicle Screw Bone Awl Cleared 05/15/2023

Guide on Reporting Animal Drug Shortages 05/15/2023

Orphan Status for Pyxis Pancreatic Cancer Therapy 05/12/2023

Cordis Class 1 Recall of Angioguard System 05/12/2023

Congress Urges More FDA Attention to Rare Diseases 05/12/2023

FDA Encourages Voluntary Device Shortage Notices 05/12/2023

Panel Backs Epinephrine Nasal Spray 05/12/2023

FDA Eases Blood Donor HIV Recommendations 05/11/2023

Cook Tracheostomy Introducer Recall is Class 1 05/11/2023

FDA OKs Rexulti for Alzheimer’s Agitation 05/11/2023

More Groups, Experts Back KEI Ad Music Petition 05/11/2023

FDA Planning for Future Public Health Issues 05/11/2023

Sibel Health Infant Monitor Cleared 05/11/2023

Complete Response on Bladder Cancer BLA 05/11/2023

PhRMA on FDA Negative Controls Workshop 05/11/2023

CRN Asks FDA to Reconsider Drug Preclusion 05/11/2023

Abbott MRI Labeling OK’d for Spinal Stimulator 05/11/2023

Study Data Technical Conformance Guide 05/11/2023

Stakeholder Ideas on FDA Electronic System Draft 05/11/2023

FDA Wants Updated Labeling on Some Stimulants 05/11/2023

Panel to Discuss Pediatric Oncology Dose Optimization 05/10/2023

CDER Publishes AI/ML Discussion Paper 05/10/2023

Reviewers Question Sarepta DMD Drug 05/10/2023

Bill Would Force Drug Research Cost Disclosure 05/10/2023

FDA Clears Renuvion Handpiece 05/10/2023

Panel Unanimously Backs OTC Contraceptive Pill 05/10/2023

Glycol Testing Guidance 05/09/2023

CGMP Violations in Premier Nutra Pharma Inspection 05/09/2023

Court Backs FDA in Somatuline Depot Case 05/09/2023

FDA Clears Cumulus EEG Headset 05/09/2023

AI/ML Predetermined Change Control Plan Guidance 05/09/2023

FDA Reviewers Question ARS-1 Development Program 05/09/2023

Clinical Hold Lifted on Diarrhea Trials 05/08/2023

Singlera ‘Breakthrough’ on Pancreatic Cancer Assay 05/08/2023

2-Day Workshop on Generic Research Iniitiatives 05/08/2023

Samsung Irregular Heart Monitor on Watch Cleared 05/08/2023

De Novo Marketing of 2 Covid Serology Tests 05/08/2023

Califf Warns of Regulation of Large Language Models 05/08/2023

FDA Releases Sun Non-compliance Letter 05/08/2023

New Web Page on Antimicrobial Susceptibility Tests 05/05/2023

Fibrogen Misses Endpoint in Roxadustat Anemia Trial 05/05/2023

FDA Issues Ajinomoto Bio-Pharma 3-item 483 05/05/2023

PhRMA, Others Petition Against Drug Importation 05/05/2023

Actual Use Study Flagged in OTC Birth Control NDA 05/05/2023

Levitra Not Withdrawn Due to Safety/Efficacy 05/04/2023

Guide on Decentralized Clinical Trials 05/04/2023

Reject Rexulti Alzheimer’s sNDA: Public Citizen 05/04/2023

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