European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

European Pharmaceutical Review

JULY 8, 2024

Information can be found in certain US pharmacopeia guide chapters, such as USP <1116>, 1 as well as guidance from the US Food and Drug Administration (FDA) and World Health Organization (WHO) but none of these are regulatory requirements. From this observation, all options are possible.

Food and Drug Administration 95

Food and Drug Administration Pharmaceutical Pharmaceutical manufacturing Pharma 95

European Pharmaceutical Review

FEBRUARY 24, 2023

The removal/separation of impurities and ensuring the purity of biologics is essential to the safety and quality of the therapeutic. With a myriad of potential techniques that could be applied to purify new protein drugs, years of experience will be needed to know the best approach to take to optimise yield, purity and cost.

Food and Drug Administration 98

Food and Drug Administration Engineering Specialization Food 98

Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval of iTFlow® will enable healthcare professionals to make more precise and effective decisions in patient care. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc. Dr. Itatani, MD, Ph.D.,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

LEVO Health

OCTOBER 26, 2022

Food & Drug Administration (FDA) classifies medical devices. They have regulatory controls and marketing pathways you have to follow based on the risk of your device and its overall safety and effectiveness. Class II: requires general controls and special controls with and without exemptions and poses a moderate risk.

Medical 52

Medical Marketing Patients Food and Drug Administration 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52

Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Rep-Lite

SEPTEMBER 21, 2024

Key traits to look for in medical sales reps: Strong communication skills Adaptability to changing markets A deep understanding of medical device sales strategies Problem-solving abilities Self-motivation and resilience Recruitment strategies include networking at industry events, leveraging LinkedIn , and working with specialized recruiters.

Medical sales 52

Medical sales Sales Medical Medical sales reps 52

PM360

APRIL 4, 2025

Importantly, across all 11 patients between the ages of 1 and 11 who were dosed with RGX-202, there have been no serious adverse events or adverse events of special interest, such as drug-induced liver injury, which was the cause death for the 16-year-old boy after being treated with Elevidys.

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

Medical sales 130

Medical sales Medical Sales Patients 130

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

Medicine 116

Medicine Food and Drug Administration Transportation Distribution 116

Pharmaceutical Technology

JULY 29, 2022

On 25 June, Pfizer and BioNTech (Mainz, Germany) reported pivotal Phase II/III data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates. Australia’s Therapeutic Goods Administration (TGA) granted a provisional determination in April to Moderna’s Omicron jab, and in July to Pfizer’s Omicron jab.

Manufacturing 52

Manufacturing Food and Drug Administration Marketing FDA 52