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Regulatory Focus™ > News Articles > 2019 > 2 > Global Guidance, Medical Device Technology and Regulatory Intelligence

Global Guidance, Medical Device Technology and Regulatory Intelligence

Posted 01 March 2019 | By Gloria Hall 

Global Guidance, Medical Device Technology and Regulatory Intelligence

February feature articles covered medical device technology challenges, artificial intelligence applications and regulatory intelligence strategy. Global experts also shared their experience on labeling activities for drugs and biologics, the future of the laboratory developed test (LDT) regulation, China’s new drug and device inspection regulations and new guidance for oncology drug development.

Medical Device Technology

Regulatory experts Stephen Amato and Nethra Bhaskar look at various types of cardiac monitoring devices (CMDs) available and their usefulness in remote cardiac monitoring for the early detection and treatment of arrhythmias. “Impact of Innovative Healthcare Technologies: Regulatory Concerns of Ambulatory Cardiac Monitoring Devices” focuses on the technological innovations incorporated into these devices and this technology’s impact on the healthcare industry, regulatory challenges associated with their clinical utilization and potential solutions to those challenges.

By 2018, a significant number of artificial intelligence (AI) applications had been developed for use in healthcare. For example, 2018 saw the first medical device using AI to provide a screening decision—without the need for a clinician’s opinion. Experienced regulatory professional Pei-Ting Sarah Chou explores the topic in “The Emerging Role of Artificial Intelligence in Healthcare,” presents current and future AI healthcare applications, examines AI’s potential for adding efficiency to pharmaceutical research and medical practice and suggests the potential for providing better healthcare and patient diagnostic and treatment outcomes. The article also examines AI applications’ ethical concerns, the potential for misuse and the case for developing ethical standards.

Regulatory Intelligence

Regulatory intelligence professionals support the drug development process with strategic information, serve as liaisons with regulatory agencies and channel information to appropriate stakeholders. In “Regulatory Intelligence Communication for Business Impact,” regulatory experts Kirsten Messmer and Charity-Anne Schuller present an overview of applicable delivery methods and general considerations for communicating information via spreadsheets, text documents, slide presentations, strategy reports and competitive intelligence reports. The authors explain how to maximize regulatory intelligence when responding to specific stakeholder requests and offer recommendations for clear communication.

Pivotal studies have been completed, data has been analyzed and the marketing application has finally been submitted to the US Food and Drug Administration (FDA). What happens next? In “Regulatory Labeling: Preparing for Launch,” regulatory pro Heather Hammond discusses US labeling activities for drugs and biologics from postsubmission of a New Drug Application (NDA), Biologics License Application (BLA) or supplemental NDAs/BLAs to approval. The author recommends useful FDA manuals and information and covers FDA labeling comments, team planning procedures, roles, responsibilities and timelines, negotiation processes and final approval.

Global Guidance

While the future of the laboratory developed test (LDT) regulation still is very uncertain, Congress has introduced a new draft proposal, The Verifying Accurate Leading-Edge IVCT Development (VALID) Act of 2018, aimed at making regulatory changes for LDTs. In “The Proposed VALID Act: A Possible Next Step in FDA’s Goal of Regulating LDTs,” regulatory law attorneys Jeffrey Gibbs and Allyson Mullen discuss the draft proposal, identify important points about the draft and offer analysis and commentary on proposed changes to classification and premarket review, precertification, registration and notification and appeals. They suggest if the draft VALID Act became law, it would have far-reaching and potentially negative consequences for physicians and their patients.

Regulatory consultant Yingying Liu discusses the most recent drug and medical device inspection regulations imposed by China’s National Medical Products Administration (NMPA) and their impact on foreign manufacturers. In “New Regulations Imposed on Overseas Inspections of Drugs and Medical Devices,” the author covers inspection details from four of the new regulation’s chapters, all pertaining to general provisions, inspection planning, inspection conduct, the inspection report and inspection outcomes. The author discusses a regulation annex covering inspection notification, overseas inspection drug information, site master documents list (for drugs and medical devices), overseas pre-inspection notification and the overseas inspection report.
To reshape and modernize cancer research, in 2018, the FDA released four guidance documents related to oncology drug development. In “FDA’s Oncology Clinical Trial Makeover,” regulatory leaders Pat Mann, Kirsten Messmer and Luis Arthur Pelloso provide an overview of new guidances related to oncology drug development and review the pilot programs targeting faster access to new, innovative treatments without increasing risk to patients.

What’s Coming in March

The March theme is working with other markets and we’ve lined up global experts to share their insights on New Zealand’s new regulatory regime, China’s new fast marketing authorisation approval program and the state of the Chinese pharmaceutical market, Japan’s SAKIGAKE designation, regulatory pathways for orphan diseases and rare pediatric diseases and global planning and submission considerations for animal drugs. Look for these and other topics throughout March.

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