Regulatory Focus Articles

This Week at FDA: PDUFA VII guidance, COVID strain selection meeting, and more

about 2 years ago

Welcome to another installment of This Week at FDA, your weekly source...

FDA wants feedback on testing methods for new nitrosamines

about 2 years ago

The US Food and Drug Administration (FDA) is requesting stakeholder input on...

Study: Most oncology drugs approved in Japan based on surrogate endpoints do not undergo confirmatory trials

about 2 years ago

Oncology drugs approved in Japan over the last 20 years are increasingly...

MedCon: Tips for navigating the device recall process

about 2 years ago

COLUMBUS, OH – Device recalls often take more than a year to...

Recon: FDA greenlights first-ever vaccine targeting RSV; Eli Lilly plans to seek FDA approval for Alzheimer’s drug

about 2 years ago

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

Euro Roundup: Swissmedic clarifies how foreign manufacturers can demonstrate GMP compliance

about 2 years ago

For companies that cannot use either of the preferred means of demonstrating...

Stakeholders want more clarity from FDA on using data from externally controlled trials

about 2 years ago

The draft guidance describes using externally controlled clinical trials in evidence for...

MedCon: Consider the device risk management file a ‘living document’

about 2 years ago

“We need to establish that risk management doesn’t end when you initially...

Why regulatory affairs is like a bunch of 'mini-investigations’

about 2 years ago

FDA issues draft guidance on decentralized clinical trials

about 2 years ago

In a newly released draft guidance, the US Food and Drug Administration...

MedCon: Supply chain challenges evolve post COVID-19

about 2 years ago

COLUMBUS, OH – While sky-high demand was one of the key drivers...

Recon: Pfizer tops expectations on strong demand for COVID products; FDA halts Sun Pharma’s dermatological drug trials

about 2 years ago

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