EY has announced the launch of EY Smart Reviewer, a technology-driven solution that leverages artificial intelligence (AI) and natural language processing to help accelerate and improve the process to review materials used to market pharmaceutical and medical device products.
”The industry's current Medical, Legal, Regulatory Review (MLR) process, which helps to ensure marketing materials comply with regulatory guidelines, is often slow, inconsistent and requires significant manual review times for documents. There are also significant risks if off-label or other non-compliant messaging are hastily approved. Non-compliance with regulations can result in millions of dollars in regulatory fines, as well as delay actively promoting essential new therapies in the market.
The EY Smart Reviewer solution “makes it possible for pharmaceutical and medical technology companies to automate the Medical, Legal, Regulatory Review (MLR) process and significantly shorten review and approval timelines for modular content, thus driving faster speed to market for essential medicines,” said EY in a press release. “It increases speed by eliminating key manual tasks and automating the remaining tasks and it reduces costs by freeing up high-value people to focus on higher value-adding omnichannel activities, while lowering risk of regulatory fines.” I
Twelve machine learning modules make up the solution, with new modules being developed and added over time. Currently available in English, EY Smart Reviewer will also be available in French, German, Spanish, Italian, Japanese and Chinese by early 2022.
Asembia 2025: Therapy Advancements Highlight Growing Cost and Access Concerns
April 30th 2025Fran Gregory, VP, emerging therapies, Cardinal Health, discusses the evolving cell and gene therapy landscape, highlighting pipeline growth, cost challenges, and emerging therapeutic areas beyond oncology and hematology.
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
FDA Approves AbbVie’s Rinvoq as First Oral JAK Inhibitor for Giant Cell Arteritis
April 30th 2025AbbVie secures FDA approval for Rinvoq as the first oral Janus kinase inhibitor indicated for giant cell arteritis, expanding its immunology portfolio and signaling strategic growth opportunities in underserved autoimmune markets.