News and Insights

Strategic Approaches to Regulatory and Compliance

Germany Post AMNOG: Insights for BioPharma

BioPharm International

Manufacturers exploring opportunities in global markets face dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements—all of which differ from one country to another. While emerging markets continue to represent a new channel of demand for pharmaceutical products, manufacturers have quickly realized that significant attention must still…

Integrating RWE into Investigator Initiated Trials

Pharmaceutical Compliance Monitor

Expanding government and payer requirements for additional data on products, whether for safety monitoring, efficacy confirmation or economic and clinical value evaluation, underscore the importance of an integrated strategy for investigator initiated trials (IIT) and real world evidence (RWE) research. In developing an IIT/RWE strategy, companies need to be clear…

Sunshine and Transparency: Building Positive Industry-Physician Relationships

As life sciences companies address Sunshine Act requirements and other growing demands for transparency, they also face concerns from physicians that this publically available information may distort the often necessary and beneficial aspects of relationships physicians maintain with industry. Already, anecdotal evidence indicates some physicians will be reluctant to work…

Transparency in Investigator Initiated Trials

MX: Medtech Executive

Professional relationships with physicians are extremely important sources of collaboration for medical products companies. Physicians provide technical input, identify unmet needs, and perhaps most critically, conduct clinical trial administration and oversight. But these very areas have been underlined by OIG and DOJ investigators as targets of special scrutiny going forward.…

The Medical Voice — From Product Development to Post-Market Surveillance

Numerof Brief

The medical device industry is in the midst of a redefining transformation, posing both opportunities and threats to manufacturers’ current business model. Global device companies must address significant operational challenges to ensure that monitoring and safety surveillance practices address growing concerns about the safety of products introduced to the market.…

Post-Market Safety Surveillance and Medical Devices

MD&DI

Medical device companies face an expanding set of legal and regulatory requirements to address risks and concerns around product safety. Scrutiny from the public and regulators increasingly focuses on safety concerns, as demonstrated by the FDA’s recent changes to the 510(k) process and draft guidance for post-market safety. As product…