Tag: consulting 104 results

In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval....

An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect safety and effectiveness data.[1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This...

“Artificial Intelligence (AI) and Machine Learning (ML) as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. ML is considered a subset...

What is the Type D meeting? The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. This new meeting is designed to make it easier and...

All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. Periodically, the FDA updates these forms to...

In this second of our two-part series, we continue our discussion about significant recent developments regarding the regulation of ophthalmic products and discuss what to expect in the months ahead. Unsurprisingly, the U.S. Food and Drug Administration’s (FDA) released updated...

The global ophthalmic drugs market size was valued at $33.81 billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030[1]. Given this trend, many biopharmaceutical companies are investing in strategies to develop and commercialize new...

Almost 15 years after its last update, the Electronic Common Technical Document (eCTD)’s latest version has been finalized and is being rolled out internationally. eCTD v4.0 offers significant advancements in the way that sponsors and regulatory bodies handle submissions, and...

For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Together, they describe suggested development and validation activities for the...

For researchers who are developing or working with analytical procedures, the new ICH Q14 Analytical Procedure Development and revised ICH Q2(R2) Validation of Analytical Procedures drafts represent foundational guidance documents. Together, they describe suggested development and validation activities for the...