Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

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Clinical Trials Trials Production Regulations 52

Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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Vaccine Trials Disease Treatment 108

Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. OPEQ is organized into eight “Offices of Health Technology” (OHTs), which are structured by therapeutic area (e.g.,

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

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