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 ...

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

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.

The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2026 across its prescription drug, generic drug, biosimilar, and medical device programs. The rates are ...

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 ...

PDG said selection of the Korean Pharmacopoeia was a consensus decision that @reflects the quality of the Korean Pharmacopoeia@s application and its alignment with the PDG@s mission to promote global ...

The US Food and Drug Administration (FDA) kicked off the reauthorization process for the eighth iteration the Prescription Drug User Fee Act (PDUFA VIII) on Monday, with FDA Commissioner Marty Makary ...

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 ...

The US Food and Drug Administration (FDA) has issued a slew of warning letters to companies for marketing products unapproved or adulterated products, failing to meet current good manufacturing ...

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.

Sydney, AU — 21 July 2025 —The Regulatory Affairs Professionals Society (RAPS) and the Medical Technology Association of Australia (MTAA) just concluded the Australia Regulatory Device Summit 2025, ...