Medical and Regulatory Affairs

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Outsourcing: Reimagining the Patient Experience in an Evolving Clinical Trial Regulatory Landscape

“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring...

ChinaTrials 13

Booth 4

China International Medical Device Regulatory Forum (CIMDR)

Booth A20

Protected: PREMIER VOICES #15: Understanding EU Regulatory Requirements in Gene Therapy Development

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The Medicine Maker: The Winding Road to the Frontline for Advanced Therapies

According to the Alliance for Regenerative Medicine, there were 1,085 active advanced therapy medicinal product (ATMP) developers and more than 150 phase III trials underway at the end of 2020. These numbers are not small, and they make it clear that ATMPs have much to offer in helping us overcome as-yet undefeated diseases.ATMPs are different...

Medical Design & Outsourcing: Software as a Medical Device: Here’s How the Regulatory Landscape is Changing

Software as a medical device (SaMD) has emerged as a class of devices for collecting, processing and analyzing healthcare data to manage disease. Powered by analytics, SaMD accelerates the diagnosis and treatment of a wide range of medical conditions and is automating certain aspects of patient care, saving time and improving health outcomes. Because the...

PM360: How COVID Has Reshaped the Clinical Trial Regulatory Landscape

The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage...

Gene Therapy for Parkinson’s Disease: Strategies and Operational Requirements

Introduction Gene therapy holds great promise as a potential treatment for Parkinson’s disease, a disorder for which currently available medications do not causally treat the underlying disease mechanisms. However, given the early stage of gene therapy research in this therapeutic area, questions abound regarding its utility and practicality in treating Parkinson’s disease. Those questions have...

New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials

Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life, and these insights can be particularly valuable in oncology research. However, there has been a lack of guidance to help sponsors ensure consistency and quality when incorporating PROs into cancer drug...

ANDA or 505(b)(2): Choosing the Right Abbreviated Approval Pathway for Your Drug

For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of these applications rely on the agency’s finding of safety and effectiveness for a listed drug,...