Regulatory Affairs Professionals Society

Recon: Novartis to acquire Myricx Bio for $1.1B; Republican lawmakers press FDA to ensure trials are diverse

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

Asia-Pacific Roundup: India updates cell and gene therapy rules to ensure uniform regulation

The Indian government has strengthened oversight of cell and gene therapies by bringing the novel modalities into the ...
Regulatory Affairs Professionals Society

Recon: FDA approves Vertex gene therapy for children with sickle cell disease; Judge blocks Colorado price cap on Amgen’s Enbrel

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

Euro Roundup: Notified bodies propose changes to Commission plan for risk-adaptive device surveillance

Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance ...
RAPS

News & Insights Search

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...
RAPS

News & Insights Search

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
Regulatory Affairs Professionals Society

This Week at FDA: FDA names PreCheck participants, TAP open to all OHT devices, 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 asked to clarify AI pilot objectives for early-phase clinical trials

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...
Regulatory Affairs Professionals Society

FDA warns firms for marketing unauthorized devices, shoddy complaint handling

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating ...