Regulatory Affairs Professionals Society

Recon: FDA denies Hengrui-Elevar liver cancer drug for the third time; GSK to pursue FDA nod for Jemperli for rectal cancer

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

Asia-Pacific Roundup: India cuts prices of more than 30 drugs and biologics

India’s National Pharmaceutical Pricing Authority (NPPA) has announced price reductions for more than 30 drugs and biological ...
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Enterprise Membership

Develop your team. Strengthen performance. Drive regulatory excellence. RAPS Enterprise Memberships help organizations and companies invest in their people through scalable access to education, ...
Regulatory Affairs Professionals Society

FDA proposes rule to ease registration for distributed manufacturers, require foreign API sites to register

The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing ...
Regulatory Affairs Professionals Society

FDA admonishes companies for marketing unauthorized products, making misleading claims

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...
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 ...
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Tampons: FDA toxicological study finds negligible levels of toxic metals

Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found ...
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 ...
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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

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 ...