Regulatory Affairs Professionals Society

Experts weigh in on FDA’s transparency roadmap

The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and ...
RAPS

EMA plans major update to pharmacogenomics guideline

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than a ...
Regulatory Affairs Professionals Society

Convergence: Regulators highlight efforts to streamline the European regulatory framework

A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
RAPS

Recon: Bayer plans for $2.2B manufacturing site in Ohio; FDA’s CDER launches clinical trial modernization office

Food & Nutrition FDA found Cyclospora during Taylor Farms inspection in Mexico (New York Times) (AP News) EU-funded project to develop novel technologies for continuous microbial monitoring in poultry ...
RAPS

Asia-Pacific Roundup: TGA starts 5-year transition to new Australian medicine labeling standards

Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements. The old ...
RAPS

FDA’s device center releases guidance agenda for FY 2027

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...
RAPS

Convergence: CBER expert offers tips for effective BLA submissions

CHARLOTTE, NC — When submitting a biologics license application (BLA), it is important to engage with the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) early, make every ...
RAPS

WHO drafts updated guideline on quality risk management

The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their ...
RAPS

HHS launches ARPA-H project to speed clinical trials

The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the ...
RAPS

Recon: FDA approves drugs for Parkinson’s, bile duct cancer, rare soft tissue disease; Merck, Daiichi scrap application for ADC in lung cancer

Food & Nutrition FDA warns three Northeast food importers about missing supplier verification programs (Food Safety News) Testing finds widespread microplastics, lower heavy metals in baby foods (Food ...
RAPS

FDA call for new adcomm members signals renewed interest in outside advisors

The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...