The UK has set out plans to get new medicines to patients three to six months sooner by coordinating regulatory and reimbursement processes.

The International Council for Harmonization (ICH) has released a draft Q3E guideline that offers a harmonized framework for assessing and controlling extractables and leachables (E&L) in ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Supply chain experts said that most manufacturers successfully implemented the enhanced tracing requirements outlined in the Drug Supply Chain Security Act (DSCSA) by the 27 May deadline without ...

Medtech industry stakeholders said they want greater clarity and flexibility in the US Food and Drug Administration@s (FDA) recent draft guidance on submitting questions electronically to the agency ...

The 70th IPSF World Congress aims to address pressing global health challenges and improve healthcare outcomes through enhanced pharmacy education and practice. Join us for this highly relevant and ...

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...

The US Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) have laid out several principles for cancer drug developers to ensure more nuanced dosing. The principles ...

This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.

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, FDA ...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) this week released a white paper aimed at encouraging the use of selective safety data collection (SSDC).

The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to propose an indefinite recognition of CE-marked medical devices and new pathways to get devices on the market that have ...