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Senator Calls on FDA to Probe Respironics 10/11/2023

Former FDAer Beitz Joins Law Firm 10/11/2023

FDA Needs to Define ‘Substantial Equivalence’ 10/11/2023

Ozempic Kidney Study Stopped Due to Efficacy Data 10/11/2023

No Care Access Issues in VALOR Trial: Company 10/11/2023

Cytoxan Not Withdrawn Over Safety/Efficacy 10/11/2023

Multiple Violations in Abiomed Inspection 10/10/2023

2 Unapproved GLP-1 Drug Marketers Warned: FDA 10/10/2023

Suggested Changes to ‘Underrepresented’ Draft Guide 10/10/2023

‘Minor Updates’ to 2 Magnetic Resonance Guidances 10/10/2023

Researcher Cited for ‘Objectionable Conditions’ 10/10/2023

FDA Cautions About Compounded Ketamine 10/10/2023

FDA QTc Draft Guidance ‘Too Vague’: NCHR 10/10/2023

CDRH Plans 24 Guidances in FY 2024 10/10/2023

FDA Diversity Plan Draft Guidance Due: RAPS 10/10/2023

Positive Keytruda Data in Lung Cancer: Merck 10/10/2023

Companion Diagnostic for Retevmo Approved 10/09/2023

Alnylam Gets ‘Complete Response’ on sNDA 10/09/2023

Biocon Gets Insulin Aspart BLA Rejection 10/09/2023

‘Breakthrough’ Status for Knee Implant 10/09/2023

11 Dr. Reddy’s ANDAs Withdrawn 10/09/2023

HistoSonics De Novo for Tumor Blaster 10/09/2023

AstraZeneca Seeks More Input on Study Diversity 10/09/2023

Sun Pharma NDA for Alopecia Areata 10/06/2023

2 Covid-19 Product EUAs Revoked 10/06/2023

Senator Urges Justice Probe of Respironics 10/06/2023

FDA OKs Zoryve Cream Expanded Use 10/06/2023

Syndax Reports ‘Positive’ Leukemia Data 10/06/2023

FDA’s Daunting Task to Tackle Misinformation: Califf 10/06/2023

FDA Clears Home Hemoglobin Test 10/06/2023

Clinical Hold for Innate Lacutamab Trials 10/05/2023

CDRH Marks 10 Years of Cybersecurity Program 10/05/2023

Reps Reiterate Call for VALID Act Passage 10/05/2023

FDA Looking Into Counterfeit Ozempic: Report 10/05/2023

Coherus Refiles Udenyca Onbody BLA Supplement 10/05/2023

AstraZeneca Comments on FDA QTc Draft Guidance 10/05/2023

Reagan-Udall Strategies to Understand Regulated Products 10/05/2023

FDA ‘Unsatisfied’ with Philips Respironics Recall 10/05/2023

Stimulant Use Disorder Treatment Guidance 10/04/2023

Medtronic Warns on Stolen Laryngoscopes 10/04/2023

No Safety Issues in Biosimilar Switches: Study 10/04/2023

‘Objectionable Conditions’ at Florida Doctor Site 10/04/2023

Attorney Blasts CDRH for 8,000-day Petition Delays 10/04/2023

User Fee Courier Delivery Address Change 10/04/2023

Moderna Phase 3 Trial for Flu/Covid Vaccine 10/04/2023

Signature Biologics Illegally Marketing Cord Product 10/03/2023

Repeat CGMP Deviations at Fresenius Unit 10/03/2023

Oncology Panel to Discuss Accelerated Approvals 10/03/2023

More Unannounced Inspections in India: Califf 10/03/2023

FDA Reviewers Question Amgen’s Lumakras Study 10/03/2023

AdvaMedDx Challenges Oncology Test Pilot 10/03/2023

FDA Allows Reformulated Novavax Vaccine 10/03/2023

Galderma Sent Complete Response Letter 10/03/2023

Guide on 510(k) eSubmission Template 10/03/2023

Inspection Derails Lilly Eczema BLA 10/02/2023

Pilot on ANDA Model-Integrated Evidence 10/02/2023

Case Study in Corruption: Jeff Shuren’s CDRH 10/02/2023

Novo Nordisk’s Rivfloza OK’d for Rare Disease 10/02/2023

FDA Clears AI Heart Failure Detector 10/02/2023

Government Shutdown Likely This Weekend 09/29/2023

FDA Proposed Rule on Lab-Developed Tests 09/29/2023

Graft-versus-Host Disease Guidance 09/29/2023

De Novo Device E-filing Guide 09/29/2023

Guide on Drug Dose Banding 09/29/2023

FDA Approves Biogen’s Actemra Biosimilar 09/29/2023

Generics Office Expands In-person Meetings 09/29/2023

De Novo e-Submission Template Guidance 09/28/2023

Petition Seeks Warning on Fluoroquinolone Guides 09/28/2023

BrainStorm Cell Therapy Rejected by Panel 09/28/2023

FDA OKs Amicus Pompe Disease Combo Drugs 09/28/2023

265 Suicidal Reports on GLP-1 Drugs: Reuters 09/28/2023

Physiologic Closed-Loop Control Guidance 09/28/2023

Graft-vs-Host Product Development Guidance 09/28/2023

FDA OKs Pfizer’s Bosulif for Pediatric CML 09/27/2023

Ileus Added to Ozempic Label Adverse Effects 09/27/2023

Gilead Ends AML Trial of Magrolimab 09/27/2023

Prescription Information Modernization Bill 09/27/2023

Boston Scientific’s AVVIGO+ Guidance Device Cleared 09/27/2023

Peace Wellness Marketing Tissue Products: FDA 09/27/2023

Philips Hid Breathing Machine Complaints: Report 09/27/2023

Nephron Pharma Hit Again with FDA-483 09/27/2023

Device QS Cybersecurity Guidance 09/26/2023

FDA Rejects Anti-Sweating Gel 09/26/2023

FDA Pushing EG, DEG Testing 09/26/2023

Guilty Plea in Adulterated HIV Meds Case 09/26/2023

FDA ‘Cut Corners’ to Approve Hetlioz ANDA: Vanda 09/26/2023

Upcoming CBER Changes Explained 09/26/2023

Drug Use Software Guidance Analyzed by Attorneys 09/26/2023

Novartis Touts Positive Lutathera Phase 3 Data 09/25/2023

FDA Reviewers Dismiss ALS Therapy Benefit 09/25/2023

FDA Clears Profound Medical Ablation Module 09/25/2023

VistaPharm Recalls Sucralfate Lot 09/25/2023

Coherus Gets Complete Response on Udenyca 09/25/2023

Manufacturing Resumes at Damaged Pfizer Site 09/25/2023

FDA Releases Novo Nordisk FDA-483 09/22/2023

Government, FDA Shutdown Appearing More Likely 09/22/2023

Guide on Inspection Alternative Tools 09/22/2023

Senators Urge FDA to Strengthen Opioid Studies 09/22/2023

Legislation Introduced to Improve Device Recalls 09/22/2023

Panel Votes Down Intarcia Diabetes Implant 09/22/2023

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