The US Food and Drug Administration (FDA) has launched a new artificial intelligence (AI) tool nearly one month ahead of schedule that the agency says significantly improves operations and is aimed at ...

ICH also touted its Q1 guideline on stability testing of drug substances, which was released for comment after reaching Step 2a/b in April just before the Madrid meeting, as well as its final E6 (R3) ...

As of 30 September 2023, the FDA says 279 NDAs with PMRs/PMCs were held by unique applicants and 120 BLAs with PMRs/PMCs. There were 759 NDAs and BLAs with an annual status report (ASR) due in FY 2023 ...

Our intention for this book is to advance our profession and the medical device field by collaboratively sharing knowledge. This book is built on the collective expertise of over 75 dedicated ...

The US Food and Drug Administration (FDA) on Tuesday announced a new framework for licensing COVID-19 vaccine boosters that would move away from the agency’s more universal approach to boosters to ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This Week, the ...

Pharmaceutical industry groups in the EU are requesting more information on how to conduct decentralized trials to encourage their adoption. They also emphasized the need for clearer guidelines on ...

“These new credential holders are poised to provide companies and health authorities worldwide with regulatory support to ensure products reach global markets in a safe and effective manner,” said ...

BRUSSELS – While structured dialogs with notified bodies don't offer the same opportunities for feedback to medtech companies as presubmission meetings with the US Food and Drug Administration (FDA), ...

Practice Exam Digital Flashcards Curated e-learning material mirroring the exam outline and organized by domain. Available in both text and audio formats, allowing you to read, listen, or do both.

The Trump Administration is seeking $6.8 billion to fund the US Food and Drug Administration (FDA) in FY 2026 – an 11.5 percent cut from its current budget authority – with the agency looking to ...

Singapore’s Health Sciences Authority (HSA) is running a consultation into plans to exempt more types of artificial intelligence (AI)-software as a medical device (SaMD) products from its license and ...