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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

Name NIH in Drug Patent Applications: GAO 05/04/2023

Xortx to Pursue Accelerated Approval for Xorlo 05/04/2023

Device Regulatory Science Tool Catalog Update 05/04/2023

Califf Recommends FDA Reforms for Pandemic Bill 05/04/2023

FDA Novo Nordisk Concizumab Complete Response Letter 05/04/2023

Members of Congress Seek Mifepristone Reversal 05/03/2023

Rentschler Biopharma Germany Site 483 05/03/2023

Lilly Eyes Fast OK for Donanemab in Alzheimer’s 05/03/2023

GSK Wins Approval for 1st RSV Vaccine 05/03/2023

ICH Quality Risk Management Guidance Published 05/03/2023

Innovative Manufacturing Approaches Notice Corrected 05/03/2023

PDUFA User Fee Assessment Guidance 05/03/2023

Reps. Question FDA Pace for New Covid Therapeutics 05/03/2023

Trade Groups Comment on Externally Controlled Trials 05/03/2023

Smart Heart Toilet Seat Cleared by FDA 05/03/2023

Accelerated Approval Withdrawals Likely to Increase: Attorneys 05/02/2023

CGMP Violations in Voyant Beauty Inspection 05/02/2023

Decentralized Clinical Trial Recommendations 05/02/2023

DirectSync Gets ‘Breakthrough’ on Spinal Fusion Device 05/02/2023

Vanda Says FDA Disclosed Trade Secrets to Competitors 05/02/2023

FDA Finishes Posting OTC Drug Deemed Final Orders 05/02/2023

FDA Partial Hold on Sun JAK Inhibitor Trial 05/02/2023

Astellas/Pfizer Mulling sNDA for Xtandi 05/01/2023

Bipartisan Bill on Preventing Drug Shortages 05/01/2023

Complete Response on Hypoparathyroidism NDA 05/01/2023

Princeton BioMeditech OTC Covid Test Authorized 05/01/2023

Lilly Issued 483 on Aseptic Operations 05/01/2023

Medtronic Next-Gen Micra Pacemakers Approved 05/01/2023

Guide on Smoking Cessation Products 04/28/2023

Comments on Data/Tech Strategic Plan 04/28/2023

DTC Research to Examine Treatment Tradeoffs 04/28/2023

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