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.

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

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 ...

On 18 July, Mexico@s health ministry took a leap toward harmonization of regulatory requirements for medicines, publishing new guidelines that allow its medicines agency to honor decisions by ...

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 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).

Recon: Novartis, Matchpoint sign $1B deal to develop anti-inflammatory drugs; FDA reinstated a quarter of jobs cut by DOGE, Makary says Recon | 24 July 2025 | Jason Scott ...

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

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 ...

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

The European Commission wants feedback from stakeholders on updating its good manufacturing practice (GMP) guidelines in EudraLex Volume 4 to account for recent advances in artificial intelligence (AI ...

To reduce the risk of aluminum toxicity in infants and adults with impaired renal function, the US Food and Drug Administration (FDA) has issued revised draft guidance to help manufacturers minimize ...