Explore Data PULSE, a platform which helps you to navigate the complex landscape of data, regulatory and IP protection concerns at each stage of the medical product life cycle. As you navigate through each key issue, Data PULSE will help you to identify and mitigate risks across multiple jurisdictions and optimize your strategy through research, market authorization and post-market study phases.

How do life sciences companies intend to leverage new and existing sources of growth? Explore the trajectory of life sciences transactions in our latest report.

As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.

In brief On 22 October 2020, the FDA approved the anti-viral drug Veklury (remdesivir) for hospitalized COVID-19 patients, making it the first drug to receive approval for the treatment of COVID-19. Before approving this drug, the FDA issued an Emergency Use Authorization for the use of Veklury in COVID-19 treatment. We will…

The search for a vaccine to prevent COVID-19 has been underway at record-pace around the world. In order to accommodate the urgent demand for a COVID-19 vaccine, the Food and Drug Administration (FDA) has been given clearance by the Secretary of Health and Human Services to issue Emergency Use Authorizations…

FDA Food Safety Modernization Act Proposed Rule to Advance Traceability of Foods Key Takeaways On September 23, 2020, the Food and Drug Administration (FDA, the Agency) released its proposal to establish additional recordkeeping requirements for those that manufacture, process, pack, or hold foods on the Food Traceability List by collecting…

With the healthcare and life sciences sector at the heart of the pandemic, we are seeing some new issues arising in the already complex world of life sciences collaborations, for both coronavirus-related and other products and therapies. The Life Sciences Collaborations: Key Considerations in the COVID-19 Era document is a…

Key Takeaway It is vital for manufacturers of market-critical drug products to survey their supply chain and current available product supply to ensure compliance with reporting requirements. Further, while FDA inspections of manufacturing facilities in China are currently not taking place, the FDA has increased import sampling and screening in…