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

The Regulatory Affairs Professionals Society (RAPS) has started a networking group for regulatory professionals in Belgium, partnering with local regulatory professionals to create a community for ...

The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program ...

The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after ...

After completing my industry rotation as a 4th year pharmacy student, I knew I wanted to pursue a career in regulatory affairs (RA) advertising and promotion (ad promo). I had the opportunity to ...

The US Food and Drug Administration (FDA) on Monday finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.

Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain ...

The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making aimed at ...

This article offers best practices for company communication during a pandemic, such as the current COVID-19 global emergency.

The US Food and Drug Administration@s (FDA) office responsible for approving cancer therapies has been renamed the Office of Oncologic Diseases (OOD) and restructured to add new divisions, the agency ...

The US Food and Drug Administration (FDA) on Monday finalized guidance to help sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human ...

Expanded access, also referred to as compassionate use, is a vital pathway for patients with life-threatening diseases to gain early access to unapproved investigational medical devices. This article ...