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CDRH Qualifies Tool on Material Biostability 08/25/2023

FDA OKs New Veklury Covid Indication 08/24/2023

Akebia Plans 3rd Quarter Vadadustat NDA Resubmission 08/24/2023

Fast Track for Abdominal Aneurysm Product 08/24/2023

Paragonix Donor Lung Preservation Device Cleared 08/24/2023

More Drug Approval Transparency Needed: Studies 08/24/2023

FDA Approves 1st Tysabri Biosimilar 08/24/2023

Finalized Informed Consent Guidance Analyzed 08/24/2023

FDA Panel to Review Diabetes NDA Dispute 08/23/2023

Regulate Cannabis Under Existing Law: CFCR 08/23/2023

Dingell Concerned About TB from Bone Grafts 08/23/2023

Changes Sought in FDA Diabetes Endpoint Guidance 08/23/2023

Lilly’s Retevmo Hits Phase 3 Trial PFS Endpoint 08/23/2023

‘Objectionable Conditions’ in Clinical Investigation 08/23/2023

OTC Devices ‘Don’t Need Patient Self-Diagnosis’: CHPA 08/22/2023

FDA Warns Walmart, Amazon on Molluscum Drugs 08/22/2023

Ambu Illegally Selling Airway Device: FDA 08/22/2023

Clinical Hold Lifted on Sickle Cell Drug 08/22/2023

Require Generic Ozobax Safety Data: Metacel 08/22/2023

FDA Reorg Could Hurt Supplements: Duncan 08/22/2023

Drug Shortages are National Security Risk: Califf 08/22/2023

OPDP Cites Exeltis’ Promos on Social Media 08/21/2023

Device Cybersecurity Guide Coming by 9/30: FDA 08/21/2023

Eylea OK’d After Fixing Inspection Findings 08/21/2023

FDA Partial Hold on Gilead’s Magrolimab 08/21/2023

NDA for Myelodysplastic Syndromes Anemia 08/21/2023

Drug Firms’ $300 Million Fine Over Price-Fixing 08/21/2023

Califf to Put Pressure on Indian Drug Makers 08/18/2023

Anika Gains Rotator Cuff Implant Clearance 08/18/2023

Veopoz OK’d and Eylea Issues Fixed: Regeneron 08/18/2023

Merck Touts Welireg in Kidney Cancer 08/18/2023

FDA Oks Ipsen’s Sohonos for FOP 08/17/2023

Cardiosave Balloon Pump Recall Class 1: FDA 08/17/2023

BlueWind De Novo for Incontinence Device 08/17/2023

Vanda Pushes Back on Hetlioz sNDA Hearing Denial 08/17/2023

Medical Device, Drug Recalls Drop in Q2: Sedgwick 08/17/2023

Orphan Status for Biliary Tract Cancer Drug 08/17/2023

Priority Review for Servier’s Tibsovo sNDA 08/16/2023

Abortion Drug Can Remain on Market: Appeals Court 08/16/2023

FDA’s Lighter Enforcement May be Ending: Attorney 08/16/2023

New FDA PathologAI Initiative 08/16/2023

Deficiencies in CM and RTRT-D NDA Submissions 08/16/2023

Multiple Denison Pharmaceuticals Violations 08/16/2023

CDRH Prefers Guidance Comments in Table Format 08/16/2023

AstraZeneca Gets 1st OPDP 2023 Warning Letter 08/15/2023

Informed Consent Guidance 08/15/2023

QS Violations at TEI Biosciences 08/15/2023

Hold Lifted on Arcellx Myeloma Drug 08/15/2023

Info Collection Revision on BLA Procedures 08/15/2023

FDA Denies St. Jude Codeine Use Petition 08/15/2023

More Supplements Risk Oversight Coming: Califf 08/15/2023

Breakthrough Status for AngioVac System 08/15/2023

Florida Amends FOIA Lawsuit Against FDA 08/14/2023

Clinical Hold on AML Cell Therapy 08/14/2023

FDA Extends Review of Chikungunya Vaccine 08/14/2023

Phillips Recalls Trilogy EVO Ventilators 08/14/2023

Biocon Malaysia Plant Hit with 8-item 483 08/14/2023

Guide on Off-the-Shelf Software in Devices 08/11/2023

Astellas sNDA Filed for Pediatric Cresemba 08/11/2023

Ceribell’s ClarityPro For Detecting Seizures 08/11/2023

FDA Warning on 15 Universal Meditech Tests 08/11/2023

FDA On Parametric Release for Sterile Drugs 08/11/2023

Data on Under-Represented Patients Guide 08/11/2023

PAS Classification Category Guidance 08/10/2023

FDA Approves Janssen’s Talvey 08/10/2023

Underrepresented Population Data Guidance 08/10/2023

FDA Updates Regulatory Science Device Catalog 08/10/2023

Cardiosave Intra-aortic Balloon Pumps Recalled 08/10/2023

PhRMA, Others Boost FDA Discussion Paper on AI 08/10/2023

Guide on QTc Labeling Information 08/09/2023

FDA OKs Aspen IND for Parkinson’s Therapy 08/09/2023

FDA to Review Vitaris/Mapi GA Depot NDA 08/09/2023

Doctors, Health Systems Should Test Generics: Article 08/09/2023

Law Settles ‘Active Ingredient’ Debate 08/09/2023

5 Pharmas Settle Improper Reimbursement Case 08/09/2023

FDA Grants Traditional Approval to Gavreto 08/09/2023

Galera Gets ‘Complete Response’ on Mucositis Drug 08/09/2023

Curiteva Navigation Instruments for Fusion Cleared 08/08/2023

‘Less Rigorous Standards’ in Drug Approvals: Study 08/08/2023

FDA Modernizing GCP Guidelines: Attorneys 08/08/2023

FDA Warns Overseas OTC Manufacturers 08/08/2023

CBER Allowing Device ‘In-Person’ Meetings 08/08/2023

BIO Supports FDA’s AI/ML Discussion 08/08/2023

Wegovy Hits Trial MACE Goal 08/08/2023

FDA OKs Boston Scientific Cryoablation Device 08/08/2023

QTc Labeling Information Guidance 08/08/2023

Sage Postpartum Depression Oral Drug Approved 08/07/2023

Draft Guide on Cosmetic Registration/Listing 08/07/2023

Astellas Eye Drug Approved by FDA 08/07/2023

FDA Clears Abbott’s Hematology Device 08/07/2023

Dräger Recalls Carina Ventilators 08/07/2023

Regeneron Prostate Cancer Trial Stops Enrollment 08/04/2023

FDA Floats AI Modeling to Help Assess Drug Safety 08/04/2023

Nitrosamine Acceptable Intake Limits Guide 08/04/2023

Mesoblast Sent Another Complete Response Letter 08/04/2023

Biosense Webster New Label on Cardiac Ablators 08/04/2023

FDA Floats Food-Animal Antibiotic Use Group 08/03/2023

Imeka Brain White Matter Imaging Cleared 08/03/2023

DSCSA Can Lead to Drug Shortages: Reps 08/03/2023

DSCSA Waiver, Exception, Exemption Guidance 08/03/2023

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