Regulatory Affairs Professionals Society

MDUFA VI: Draft commitment letter details enhancements, performance goals

The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical ...
Regulatory Affairs Professionals Society

FDA plans rules to rein in drug ads, enable proactive release of CRLs, and more

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...
RAPS

MDCG updates guidance on device classification, EMDN, and supply disruptions

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...
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.
RAPS

PDUFA VIII: FDA, industry make significant progress toward agreement

In the latest meeting minutes released by the US Food and Drug Administration (FDA), the agency noted that significant progress has been made toward an agreement with the pharmaceutical industry 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.
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

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

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.