Regulatory Affairs Professionals Society

EMA issues guidance on submitting ePI ahead of upcoming requirement

The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications ...
Regulatory Affairs Professionals Society

Recon: FDA approves AZ’s breast cancer drug over negative adcomm vote; Novartis sees setbacks for drugs targeting cholesterol, myotonic dystrophy

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

This Week at FDA: Foreign clinical trial scrutiny, botanical drugs, and an EUA declaration

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and ...
Regulatory Affairs Professionals Society

Industry asks FDA to expand prior knowledge guidance

Industry stakeholders want the US Food and Drug Administration (FDA) to expand the scope of its recent draft guidance on the ...
Regulatory Affairs Professionals Society

Recon: CBER official overruled Replimune melanoma drug rejection; AbbVie claims Phase 3 win for multiple myeloma drug

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
Regulatory Affairs Professionals Society

Euro Roundup: UK government moves to modernize legislative framework for medicines and devices

The UK government has filed legal amendments intended to modernize the regulation of medicines and medical devices.
Regulatory Affairs Professionals Society

EMA launches data sharing pilot to gain confidence in NAMs, reduce animal testing

The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot to allow drug developers to share ...
RAPS

North Carolina LNG In Person Event: Classroom to Career Part 2

Building on the momentum of the inaugural “From Classroom to Career” panel held in May 2026, the RAPS NC Local Networking Group returns to continue the conversation on clinical research and regulatory ...
RAPS

Regulatory Connects. RAPS Member Recruitment Drive

The RAPS Member Recruitment Drive is your chance to build a stronger community of regulatory and quality professionals. Invite a colleague to join RAPS, and you won’t just add a valuable new ...