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 ...
Regulatory Affairs Professionals Society

FDA investigator, experts seek to dispel misperceptions around 483s

Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of ...
Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
Regulatory Affairs Professionals Society

Euro Roundup: European Parliament backs temporary suspension of wastewater proposals

The European Parliament has called for the temporary suspension of plans to make drugmakers pay for wastewater treatment.
Regulatory Affairs Professionals Society

HHS and FDA propose clinical trial reforms to expedite drug development

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
Regulatory Affairs Professionals Society

FDA cites companies for CGMP violations, telehealth firms for illegally marketing GLP-1 drugs

The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to ...
Regulatory Affairs Professionals Society

DIA: Regulators tout international efforts to set AI policies

Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased ...
Regulatory Affairs Professionals Society

Recon: Biogen to acquire RayThera for $1B; FDA approves first generic version Roche flu drug

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

Regulatory Affairs Certification (RAC)

The Regulatory Affairs Certification (RAC) is the leading credential for regulatory professionals in the healthcare sector. The two RAC designations are Pharmaceuticals (RAC-Drugs) and Medical Devices ...
Regulatory Affairs Professionals Society

Recon: FDA approves Merck's Welireg-Keytruda combo for kidney cancer; FDA staff signal support for Moderna’s flu shot in older adults

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

Recon: AbbVie forges $10.9 billion deal with Apogee; US FDA changes tack on Regenxbio's rare disease gene therapy

Welcome to Regulatory Reconnaissance, your regulatory news and i ...
RAPS

Experts say FDA’s plan to reduce animal testing is already seeing success at 1 year, but challenges remain

The US Food and Drug Administration (FDA) roadmap to reduce animal testing as a requirement for drug development has already made an impact after its first year, but the initiative faces future ...