Regulatory Affairs Professionals Society

Study: Patient, consumer reps at FDA adcomms increasingly hold ties to pharma-backed advocacy groups

At some advisory committee meetings, more than half of patient and consumer representatives who attended had connections to ...
Regulatory Affairs Professionals Society

This Week at FDA: HHS staff assessments raise concerns, former FDA chiefs criticize DOGE, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
RAPS

FDA warning letters raise concerns about CGMP, GLP violations

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices (CGMP) requirements, and to a research ...
Regulatory Affairs Professionals SocietyOpinion

Experts favor a new regulatory framework for clinical AI models

Congress should enact a specific regulatory framework for artificial intelligence (AI) models developed and used in academic ...
Regulatory Affairs Professionals Society

FDA launches rare disease framework initiative

A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
RAPS

RAPS Workshop: Cybersecurity Unauthorized: The Latest in Medical Device Cybersecurity

Cybersecurity remains mission-critical for medical device manufacturers. As regulatory expectations, threats, and technologies continue to evolve, organizations must stay current with the latest ...
RAPS

Japan LNG In Person Event: Kick-off event

This is the kickoff meeting for RAPS Japan LNG. We will introduce RAPS Japan LNG, which was launched in September, and RAPS's activities, and discuss together the future vision and activities of RAPS ...
Regulatory Affairs Professionals Society

FDA seeks input on studying psychedelic ibogaine

The US Food and Drug Administration (FDA) is seeking public input on how to design early-phase clinical trials to evaluate ...
Regulatory Affairs Professionals Society

Experts weigh in on FDA’s transparency roadmap

The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and ...
RAPS

Study: Europe’s share of clinical trials is declining amid shift toward Asia

The number of clinical trials authorized in the EU and European Economic Area (EEA) has decreased by 13.5% from pre-pandemic levels as Asia has captured a growing share of clinical research. According ...
RAPS

Study pushes for greater adoption of a cloud-based regulatory environment

Broader adoption of cloud-based platforms by regulatory bodies could lead to significantly faster approval times, according to a study authored by Nina Cauchon of Amgen and colleagues published in the ...