European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

Food and Drug Administration 87

Food and Drug Administration Transportation FDA Medical 87

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting. About the author.

Medicine 89

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 89

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

European Pharmaceutical Review

MARCH 12, 2024

In the pharmaceutical/life sciences industries, maintaining data integrity is crucial given its role in making critical decisions that shape outcomes from drug development to human health. What are three current key trends in data integrity? Ensuring data integrity in the life science industry is crucial for regulatory compliance.

Government 87

Government Pharma Ethics Training 87

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 83

Manufacturing Pharma Food and Drug Administration Safety 83

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

Food and Drug Administration 76

Food and Drug Administration Safety Patients Leads 76

Legacy MEDSearch

SEPTEMBER 29, 2023

Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. ReGelTec, Inc. announced that the U.S. Vapotherm (NYSE:VAPO), and National Sleep Technologies.

FDA 52

FDA Food and Drug Administration Recruitment Medical 52