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

FDA warns firms for marketing unauthorized devices, shoddy complaint handling

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating ...
RAPS

FDA asked to clarify AI pilot objectives for early-phase clinical trials

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) ...
RAPS

These regulatory professionals are joining the RAPS Board of Directors in 2027

Three accomplished regulatory affairs professionals are set to join the RAPS Board of Directors, our society’s governing body, in 2027. Silu Zhang, Jennifer Neff, and Raymond Seda will join the board ...
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

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 ...
RAPS

BsUFA IV: Industry and FDA at impasse over reference product exclusivity

Officials from the US Food and Drug Administration (FDA) and pharmaceutical industry representatives could not reach an agreement on the number of reference product exclusions (RPE) to make each year, ...
Regulatory Affairs Professionals Society

European groups weigh in on ICH E22 guideline on patient preference studies

European groups have raised questions about how patient preference studies (PPS) can be adapted from one region to another under the International Council on Harmonization (ICH) E22 guideline. Similar ...
RAPS

This Week at FDA: HHS proposes drug acceleration initiatives, FDA warns companies about falsifying test data, and more

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 ...