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FDA Clears BD Alaris Pump Troubles 07/21/2023

Wuxi Pharmaceutical FDA-483 07/20/2023

Abiomed Recalls All Lots of 6 Heart Pumps 07/20/2023

Vir Flu Vaccine Fails Phase 2 Trial 07/20/2023

Dismiss Norwich Rifaximin Suit: FDA 07/20/2023

MediView Surgical Augmented Reality Device Cleared 07/20/2023

Using ctDNA as an Early Endpoint 07/20/2023

FDA Monitoring Drug Shortages After Pfizer Tornado 07/20/2023

FDA OKs Vanflyta for Leukemia 07/20/2023

New FDA Tools in Democrats’ Preparedness Bill 07/19/2023

Don’t Use Quidel Triage Cardiac Panel: FDA 07/19/2023

Ex-FDA Gene Therapy Guru Joins Greenleaf 07/19/2023

8 Repeat QS Violations at Edge Biologicals 07/19/2023

Ambrx Gets Fast Track for Prostate Cancer Drug 07/19/2023

FDA Clears ReddyPort Ventilation Device 07/19/2023

4 Observations in SCA Pharmaceuticals FDA-483 07/19/2023

Keytruda Hits Endpoint in Cervical Cancer Trial 07/19/2023

FDA Clears Xstrahl Skin Cancer Radiation Therapy 07/19/2023

FDA Grants Fast Track for Myelofibrosis Drug 07/19/2023

CGMP Deviations at Centaur Pharmaceuticals 07/18/2023

Outset Medical Illegally Marketing Tablo System: FDA 07/18/2023

FDA Boosts Translational Sciences ‘Achievements’ 07/18/2023

Legislators Hit FDA's India, China Inspections 07/18/2023

Akebia Resubmitting Kidney Disease NDA 07/18/2023

Medtronic Recalls Faulty Defibrillators 07/18/2023

Suggestions for Pediatric Drug Guidance 07/18/2023

GAO Regenerative Medicine Policy Options 07/18/2023

Catalent Indiana Facility Cited in Form-483 07/17/2023

Quidel Cardio Recalls Cardiac Panel Test 07/17/2023

Guide Updated on Device Development Tools 07/17/2023

Ex-FDA Chief Counsel Joins Berkley Research 07/17/2023

AstraZeneca RSV Drug Beyfortus Approved 07/17/2023

FDA Warns About Using RoyalVibe Ultrasounds 07/17/2023

Fresenius Kabi Facility Hit With FDA-483 07/14/2023

MedRhythms Stroke Neurorehabilitation System Cleared 07/14/2023

EarliTec Autism Second Gen Device Cleared 07/14/2023

Bill Introduced on Biosimilar Substitutions 07/14/2023

Guide on Postmarketing Study Noncompliance 07/14/2023

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

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