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3 GOP Senators Push FDA on Chinese Cancer Drugs 06/28/2023

Comments on OPDP Quantitative Claims Research 06/28/2023

FDA Reiterates NuVasive Device Indications 06/28/2023

Eton Pharma Gets Complete Response Letter 06/28/2023

4 Observations in Prisma Health FDA-483 06/28/2023

FDA Bars Chengdu KeCheng Drugs 06/27/2023

Supply Chain Violations at Safe Chain Solutions 06/27/2023

DTC Efficacy and Risk Information Guidance 06/27/2023

QCARD Can Improve Oncology Submissions 06/27/2023

Schumer Pushes Drug Shortage Legislation 06/27/2023

Implant Sales Rep Arrested in Fraud Case 06/27/2023

More ORA Changes Coming 06/27/2023

FibroGen Quashes Pulmonary Fibrosis Trial 06/26/2023

Draft Guide on Medical Psychedelic Drugs 06/26/2023

ReShape Lifesciences sPMA for Lap-Band 2.0 06/26/2023

FDA Approves Pfizer Alopecia NDA 06/26/2023

UCB Psoriasis BLA Review Extended 06/26/2023

CS Medical Ultrasound Probe Cleaner Cleared 06/26/2023

Hold Lifted on Pharvaris Angioedema Drug 06/26/2023

Pfizer Dumps Lotiglipron on Liver Injury Concerns 06/26/2023

Draft Guide on Medical Psychedelic Drugs 06/23/2023

Intercept Hit With 2nd Denial on NASH Drug 06/23/2023

Jazz Pharma Sues FDA Over Competitor Approval 06/23/2023

New Pathway for Breakthrough Device Coverage 06/23/2023

7-Year Echo: Marks Overrode Reviewers on Duchenne Therapy 06/23/2023

Support In-Home Opioid Disposal: AGs 06/22/2023

Rubio Questions Decision on Cisplatin Imports 06/22/2023

OTC Drug Dispute Resolution Guidance 06/22/2023

Arrow Recalls Peripheral Catheter System 06/22/2023

Indian Drug Companies Sharing Compliance Info 06/22/2023

FDA Accelerated Approval for Duchenne Gene Therapy 06/22/2023

Suggestions for Pharmacogenomic Data 06/22/2023

Add Plant-Based Diet Notice to Some Agonists: Petition 06/21/2023

‘Objectionable Conditions’ at Chicago Cornea 06/21/2023

AZ Halts Elarekibep Asthma Phase 2a Trial 06/21/2023

Complete Response Letter for Aldeyra ADX-2191 06/21/2023

Anumana Gets Breakthrough on ECG-AI Algorithm 06/21/2023

ChatGPT Companies Want Regulation: Califf 06/21/2023

Ways to Address GSI Shortages: Report 06/21/2023

Reps Urge FDA Relief on Compounded Hormones 06/21/2023

FDA Cancer Biomarker Pilot 06/20/2023

Multiple Violations at Vitang Technology 06/20/2023

Professor Calls for Alzheimer’s Drugs REMS 06/20/2023

FDA Grants, Denies BI Spiriva Petition 06/20/2023

New Areas of ICH Harmonization 06/20/2023

FDA Extends Neffy NDA Review 06/20/2023

Surmodics Drug-Coated Balloon Approved 06/20/2023

FDA Reports on State of Pharmaceutical Quality 06/20/2023

Review Extended on GSK’s Momelotinib 06/16/2023

Philips Safety Alert on Azurion/Allura Devices 06/16/2023

FDA Posts 483 of iRhythm’s CA Facility 06/16/2023

Emigality Misses Superiority in Clinical Trial 06/16/2023

Columvi Accelerated Approval for Lymphoma 06/16/2023

FDA Backs Monovalent XBB.1.5 Covid Vaccine 06/16/2023

Reps. Introduce Drug Labeling Bill 06/15/2023

Panel Backs Monovalent XBB Variant Covid Vaccine 06/15/2023

AI/ML Challenges in Precision Medicine: FDA Paper 06/15/2023

Corvus Wants FDA Meeting on CPI-818 Trial 06/15/2023

Conditional Approval for ‘Marginal’ New Drugs: Avorn 06/15/2023

FDA OKs Amendment to Uproleselan Trial 06/15/2023

Public Citizen Urges FDA to Reject Duchenne BLA 06/15/2023

American Lab’s Bowel Disease Assay Cleared 06/15/2023

FDA Partial Hold on Mersana Trials 06/15/2023

FDA to Decide Florida Drug Import by 10/31 06/14/2023

Pfizer Warns of Bicillin Shortages 06/14/2023

CDER Supports C-Path Pancreatic Markers 06/14/2023

FDA Patient Medication Information Highlighted 06/14/2023

2seventy bio Leukemia Trial Paused 06/14/2023

Starton OK’d for Multiple Myeloma Trial 06/14/2023

Device Software Submission Guidance 06/13/2023

A&Z Selling Illegal New Kids’ Drug 06/13/2023

Recorlev Web Pages ‘False or Misleading’: FDA 06/13/2023

FDA Rare Disease ARC Program Update 06/13/2023

OTC Erectile Dysfunction Gel Authorized in U.S. 06/13/2023

BIO on FDA Data, Technology Plan 06/13/2023

More Data Needed for Neffy ANDA: Viatris 06/13/2023

Wearable Smart Thermometer Recalled 06/12/2023

Phathom Pharma Resubmits Vonoprazan NDA 06/12/2023

FDA Backs New Covid Vaccine with XBB Variant 06/12/2023

Info Collection on MedSun Device Reporting 06/12/2023

Collection on Device Premarket Notification Revised 06/12/2023

MAPP on ANDA Facility Deficiency Reclassifiaction 06/12/2023

Linzess Approved for Pediatric Constipation 06/12/2023

FDA Needs New Policies for AI: Gottlieb 06/09/2023

FDA Alert on Oxygenator Recall 06/09/2023

Panel Backs Full Approval of Alzheimer’s Drug 06/09/2023

SurGenTec Sacroiliac Joint Fusion Device Cleared 06/09/2023

Bipartisan Bill on Provisional FDA Approvals 06/09/2023

FDA Sees Need to Better Address Drug Shortages 06/08/2023

Oral Contraceptive Drug Interaction Guidance 06/08/2023

Avita Skin Defect Device Get Expanded Use 06/08/2023

FDA Taps Murphy to Head Generic Drugs Office 06/08/2023

Panel Backs RSV Monoclonal Antibody 06/08/2023

Create One PPI Guidance for all Products: Novartis 06/08/2023

Assessing GDUFA User Fees Guidance 06/08/2023

FDA Ups Pediatric Exclusivity Requirements: Attorneys 06/08/2023

CBER Post-Covid Transition Information 06/07/2023

Eisai/Biogen Alzheimer’s Drug Effective: FDA 06/07/2023

Bioresearch Monitoring Issues in Mazhar Trials 06/07/2023

PMI ‘Major Change’ in Drug Labeling: Attorneys 06/07/2023

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