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

HHS and FDA propose clinical trial reforms to expedite drug development

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
Regulatory Affairs Professionals Society

DIA: Regulators tout international efforts to set AI policies

Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased ...
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.
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

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
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 will review generic GLP-1; India floats faster licensing for some devices

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

Recon: AbbVie forges $10.9 billion deal with Apogee; US FDA changes tack on Regenxbio's rare disease gene therapy

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

FDA investigator, experts seek to dispel misperceptions around 483s

Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of ...