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 ...

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

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.

A European Parliament committee has proposed changing the draft Critical Medicines Act (CMA) to reflect the impact environmental measures have on drug supply.

RAPS has recognized nine distinguished professionals and one organization with awards for their work to support the regulatory profession and advance public health. Recipients will be honored at RAPS ...

The US Congressional Budget Office (CBO) says a permanent cut to the National Institutes of Health (NIH) budget and extending drug review times at the Food and Drug Administration (FDA) would likely ...

340 Global Regulators, Health Authorities and Industry Partners Gather in Sydney for Australia Regulatory Device Summit 2025 RAPS Announcements | 21 July 2025 | RAPS ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US FDA taps biotech veteran George Tidmarsh to lead drug center (STAT) (Reuters) A sloppy report on ...

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 ...