Med Device Archives - Schlafender Hase

5 minutes read

Increased Focus on Promotional Compliance – Insights from OPDP and PAAB

In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.

7 minutes read

Med Tech in a Globalized World: Overcoming Regulatory Compliance Challenges for International Success

Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.