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 ...

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

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

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA Chief Says He Wants Gene Therapy Head Prasad to Return (Bloomberg) US to initially impose 'small ...

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 UK government has announced an ambitious plan to become the leading life sciences economy in Europe in five years and the third most important global life sciences economy by 2035. The plan ...

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 (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 ...

The US Food and Drug Administration (FDA) published on 18 July a final, 23-page guidance document clarifying how sponsors may formally meet with the agency regarding the development and review of ...

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stakeholders said they want greater clarity and flexibility in the US Food and Drug Administration@s (FDA) recent draft guidance on submitting questions electronically to the agency ...

Recon: Sarepta resumes shipments of Elevidys for ambulatory patients; Merck to cut costs by $3B Recon | 29 July 2025 | Jason Scott ...