Regulatory Affairs Professionals Society

FDA to consider ‘innovative approaches’ to psychedelic drug development

Top US Food and Drug Administration (FDA) officials said the agency is open to novel, “innovative approaches” to the clinical ...
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

FDA names permanent CDER, CBER directors, new deputy commissioner for AI

The US Food and Drug Administration (FDA) has announced the permanent appointment of four top officials to lead the agency's ...
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

Recon: Trump announces new pricing deals with midsize biotechs; Novartis pauses CAR-T trials after patient deaths

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
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, patient groups seek changes to FDA’s revised master protocols guidance

Industry and patient groups have asked the US Food and Drug Administration (FDA) to make several changes to its revised draft ...
Regulatory Affairs Professionals Society

FDA issues untitled letter to Alar for false advertising of investigational drug

Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: India simplifies regulatory framework for outsourced sterilization of medical devices

The Indian government has simplified the regulatory framework for outsourced sterilization of medical devices as part of a ...
RAPS

Lisa Wright on the evolution of rare disease regulatory policy and what comes next

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the ...
Regulatory Affairs Professionals Society

This Week at FDA: HHS considering new FDA posts, FDA approves slew of firsts, and more

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