RAPS

FDA issues untitled letters to Sanofi and Viatris for false advertising

The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement. FDA issued an ...
RAPS

MDCG: Only manufacturers should assign UDI-DIs

The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better ...
Regulatory Affairs Professionals Society

European Commission publishes guideline on transparency obligations under AI Act

The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...
RAPS

This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, 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, ...
RAPS

Experts: Ending adequate provision would shut down prescription drug ads

The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high ...
RAPS

Study: China outpaces the US in cancer approvals, lags behind on first approvals

While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first ...
RAPS

FDA cites companies for CGMP violations, informed consent failure

The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to ...
RAPS

CDER plans new guidance on AI, electronic safety report submissions, and more

CDER plans new guidance on AI, electronic safety report submissions, and more FDA headquarters in White Oak, Md. (Credit: Ferdous Al-Faruque) The US Food and Drug Administration’s (FDA) Center for ...
RAPS

Drug repurposing: Stakeholders say FDA should act within its authority, avoid disincentives

Patient and healthcare industry stakeholders told the US Food and Drug Administration (FDA) that while there are significant opportunities to repurpose existing drugs, the agency should ensure any new ...
RAPS

Recon: Lilly to buy psychedelic developer AtaiBeckley for up to $3.8B; FDA approves Merck’s novel cholesterol drug

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
RAPS

Regulatory Compliance Certification (RCC)

Validate your Knowledge. Boost your Impact. The Regulatory Compliance Certification (RCC) validates your EU MDR or IVDR knowledge and elevates your credibility in an environment where Europe’s ...