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 ...

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 ...

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.

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 ...

FDA also chastised the company for its failure to conduct stability testing program for its drug products in a timely manner. FDA said that “stability testing was overdue by 3 months or longer for a ...

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 ...

An advisory panel on Thursday urged the US Food and Drug Administration (FDA) to remove the boxed warnings on labels for vaginal estrogen products and asserted there is a lack of data to support the ...

The US Food and Drug Administration (FDA) has issued draft guidance on developing cancer drugs intended for use in combination with other therapies. The guidance focuses on demonstrating each drug@s ...