rising tide of clinical trial data is flooding the pharmaceutical industry, offering boundless potential to chart new development pathways. But it also introduces complex regulatory rip currents to navigate. As the lighthouse guiding safe passage through swollen seas, the FDA recognizes both the vast promise and potential perils of this data deluge.

any patients must abstain from animal-derived ingredients (ADI) or prefer animal-free (AF) medications due to health, dietary, religious, animal cruelty, or climate change reasons. Based on some estimates, 75% of popular medications may contain ADI (active or inactive ingredients; heparin, thyroid hormone, gummies, gelatin capsules, etc.); ADI are also present in a diverse set of medical products, such as bioprosthetics (e.g., porcine heart valves), surgical mesh, and most vaccines. This poses a problem not only in acute medical care (e.g., medications/devices used during surgery) but also in ambulatory settings.

ene therapy medicinal products (GTMPs), which in the European Union (EU) are a subset of advanced therapy medicinal products (ATMPs), may have the potential to transform the treatment landscape for many diseases ranging from inborn errors of metabolism to malignancies, offering the promise of treating diseases that may range from debilitating to fatal. The science of gene therapy (GT) was catalyzed by breakthroughs in DNA technology that led to research strategies aimed at replacing or adding genes. These techniques often employ viral vectors.

he European Union has been at the forefront of fostering innovative research projects aimed at harnessing real-world evidence (RWE) and cutting-edge data analytics to enhance healthcare decision-making.

nderstanding, collaboration, and a one-point-of-contact model were a few of the “asks” from the experts representing regulatory agencies, competent authorities, notified bodies, and industry organizations at the 2024 Combination Products in the EU Summit jointly presented by DIA and the Regulatory Affairs Professionals Society (RAPS) in January 2024 in Brussels.

n December 2023, one of the often-flashed headlines on daily newspapers and online news portals (both print and digital) in India concerned an adverse drug reaction (ADR) reported by the Indian Pharmacopoeia Commission (IPC) in their monthly Drug Safety Alert. This report was based on preliminary analysis of ADRs from the Pharmacovigilance Programme of India (PvPI) database. Surprisingly, this was neither a hitherto-unknown effect of the drug in question nor was there any new evidence implying a sudden increase in incidence, in either qualitative or quantitative terms, of the said ADR.

nnounced during the Ninth Summit of the Americas in mid-2022, the annual multisectoral forum Americas RISE for Health seeks to harness the collective strengths of the private sector and civil society of the region (comprising countries in North, Central, and South America), in partnership with the participating countries’ governments, to build the hemisphere’s supply chains to be more resilient, enable digital health solutions to reach underserved populations, accelerate regulatory improvements, reduce trade and investment barriers to health financing, create ethical environments so health economies can thrive, and address other areas of need.

here has been a contentious debate about nicotine vaporizers (vapes) in Australia. On one hand, the use of nicotine vapes registered as therapeutic goods as an aid to quitting cigarette smoking is accepted. However, this use required a prescription from a general practitioner and dispensing from a chemist, adding to the product cost.

arah McMullen is the Country Director for the FDA India Office. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned more than 20 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. In the last nine years, she has focused on international arenas, including import operations and foreign office service. She reflects on these experiences and opportunities in the below interview.

n October 6, 2023, the US Department of Health and Human Services, in conjunction with the Office of Research Integrity (ORI), proposed updates to revise the Public Health Service Policies on Research Misconduct. The proposal primarily focused on clinical research sites and did not specify how clinical trial agreements would need to be updated. Nevertheless, Clinical Research Organizations (CROs) and Sponsors must pay heed to site-level changes and update their contracts in light of their own exposure to avoid being caught flat-footed or surprised when the changes are confirmed.