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Veklury Approved for Covid Plus Renal Impairment 07/14/2023

FDA Guide on Postmarketing Noncompliance Good Cause 07/13/2023

Oncology Drug Pilot on LDT Performance Criteria 07/13/2023

Zyto Illegally Marketing Galvanic Skin Device: FDA 07/13/2023

FDA Hernia Repair Surgical Mesh Info 07/13/2023

Draeger Recalls Ventilator Over Battery Issues 07/13/2023

Cell, Gene Manufacturing Changes, Comparability 07/13/2023

Opill Approved as 1st OTC Oral Contraceptive 07/13/2023

CGMP, Other Issues at NeilMed Pharmaceuticals 07/12/2023

Disclose Drug, Supplement Animal Ingredients: Petition 07/12/2023

Boston Scientific Brain Stimulation Software OK’d 07/12/2023

FDA Warns 2 Firms on Human Cells/Tissues 07/12/2023

Most Common 2022 BIMO Violations 07/12/2023

FDA Wants More PSA Applicants 07/12/2023

Lymphoma Trial Enrollment Paused After 7 Deaths 07/11/2023

Praise for FDA Final PFDD Guidance 07/11/2023

Innovative Manufacturing Workshop Positive Comments 07/11/2023

No Higher Death Risk in Paclitaxel-Coated Devices: FDA 07/11/2023

Metabolism Inborn Errors Guidance 07/11/2023

More Study of Patient-Reported Frailty Needed: FDA 07/11/2023

SCOTUS Should Hear Label Highlights Appeal: PhRMA 07/11/2023

FDA Enforcement Discretion Policy for Pandemic Tests 07/11/2023

Takeda Withdraws BLA for Dengue Vaccine 07/11/2023

FDA Clears Avatar VR Surgical Planner 07/10/2023

Cipla Recalls 6 Albuterol Sulfate Aerosol Batches 07/10/2023

DTC Guidance May Signal Enforcement Shift: Attorneys 07/10/2023

Illumina Cybersecurity Vulnerability is Class 2: FDA 07/10/2023

Ipsen Planning FDA Elifibranor Application 07/10/2023

FDA Full Approval for Eisai’s Leqembi 07/10/2023

CRL for Regeneron Aflibercept BLA 07/10/2023

FDA to Again Try to Regulate LDTs: Attorneys 07/10/2023

FDA OKs SystImmune Phase 1 Lung Cancer Study 07/10/2023

FDA Actions Follow Advisors 88% of Time: Analysis 07/10/2023

8 Observations on Ipca Labs FDA-483 07/10/2023

CRL for Amneal Parkinson’s Drug 07/10/2023

CDER Site-Selection Model MAPP 07/10/2023

CDRH Moving to Electronic Export Docs 07/10/2023

29-Page Intas FDA-483 07/10/2023

Outset Medical Gets Tablo Warning Letter 07/10/2023

Hemogenyx CAR-T Therapy on Clinical Hold 07/10/2023

VCN-01 Orphan Status for Pancreatic Cancer 06/30/2023

Teleflex Recalls Endotracheal Tubes 06/30/2023

House Bill on Provisional Drug Approvals 06/30/2023

More Regulation Needed for Generics: Bloomberg 06/30/2023

8 Information Collections Approved by OMB 06/30/2023

FDA Allows 1st Master File Use for Sterilizer 06/30/2023

FDA WEBVIEW CLOSED JULY 4TH WEEK 06/30/2023

Rhinosinusitis Drug Development Guidance 06/29/2023

Compounding Inspection, Oversight FAQs 06/29/2023

FDA OKs 1st Diabetes Cellular Therapy 06/29/2023

Info Collection on Advisory Committee Regs 06/29/2023

18-Page FDA-483 on Ipca Laboratories Inspection 06/29/2023

BioMarin Gene Therapy for Hemophilia A OK’d 06/29/2023

Alvotech Complete Response Due to Inspection 06/29/2023

2 Roche Assays Cleared for Alzheimer’s 06/29/2023

Prioritize Cancer Trial Diversity: Researchers 06/29/2023

Orthopedic Implant Guide Guidance 06/28/2023

Oncology Drug Approval Trends 06/28/2023

CBER Updates 2023 Guidance Agenda 06/28/2023

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

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