FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software. This comparison is misplaced.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

XTalks

OCTOBER 19, 2023

This could involve tweaking experimental conditions, changing reagents or redesigning the assay. Regulatory and Compliance Knowledge Having knowledge of the regulatory landscape is particularly relevant in clinical diagnostics or pharmaceutical industries where the assays must meet specific regulatory standards. PCR, flow cytometry).

Scientist 59

Scientist Development Research Compliance 59

pharmaphorum

JUNE 1, 2021

Writing in the American Journal of Tropical Medicine and Hygiene in 2019, doctors from the US government, universities, hospitals and the pharmaceutical company Pfizer warned that the rise in “falsified and substandard medicines” has become a “public health emergency” and that poor quality drugs exact an annual economic toll of up to US$200 billion.

Medicine 52

Medicine DNA Pharmacy Production 52

The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company.

Sales 40

Sales Production Doctors Doctor 40