Regulatory Affairs Professionals Society

FDA revises compliance guide on pre-approval inspections for pharmaceuticals

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for ...
RAPS

FDA revises compliance guide on pre-approval inspections

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions ...
Regulatory Affairs Professionals Society

Recon: Vertex buys Crinetics for $10B; EMA fast tracks Revolution’s metastatic pancreatic cancer drug

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

Industry groups ask FDA for transparency, predictability, and expansion with CNPV

Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to ...
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

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 ...
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 ...
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

Asia-Pacific Roundup: India expands mandatory use of QR codes for traceability, starts phased transition

India has adopted legislation expanding the mandatory use of QR codes for tracing more drugs across the supply chain.