Regulatory Affairs Professionals Society

Recon: FDA staff raise no major concerns for Grail multi-cancer test ahead of adcomm; Trump admin drafting order to exert control over NIH grant funding

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

FDA draft guidance addresses considerations for robotically assisted surgical devices

The US Food and Drug Administration (FDA) published a draft guidance detailing its thinking on the requirements for bringing certain robotically assisted surgical devices (RASD) to market. It includes ...
Regulatory Affairs Professionals Society

Recon: Adcomm backs Grail’s cancer test; Lilly, China’s InnoCare sign $3.35B deal

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Foc ...
Regulatory Affairs Professionals Society

Recon: Pharma companies urge Trump administration to protect China deals; EU drugmakers seek faster trials, more spending to compete with US, China

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

Convergence: Regulators highlight efforts to streamline the European regulatory framework

A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
RAPS

HHS launches ARPA-H project to speed clinical trials

The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the ...
RAPS

FDA to remove ‘animal testing’ terminology from its regulations

The US Food and Drug Administration (FDA) plans to replace terminology related to animal testing with broader terms, such as “nonclinical tests” and “nonclinical studies” throughout its regulations to ...
RAPS

FDA call for new adcomm members signals renewed interest in outside advisors

The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...
RAPS

Recon: FDA approves Egetis’ Emcitate for rare genetic disease; Novo buys rights to Chinese weight-loss pill in $2.6B deal

In Focus: International Novo to pay up to $2.6 billion to China's Hengrui for rights to weight-loss pill (Bloomberg) (Financial Times) EU pharma reform package takes step forward with formal council ...
RAPS

FDA nominee Overton faces grilling in Senate confirmation hearing

Heidi Overton, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), faced questions from both sides of the political aisle about her views on hot-button issues facing ...
RAPS

Asia-Pacific Roundup: Indian government approves adverse event monitoring plan for transplantation products

The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation. Hailed by the government as a ...