Articles tagged with Regulatory Affairs
The ISSCR has released a comprehensive roadmap for developing pluripotent stem cell-derived therapies, outlining critical scientific, manufacturing, and regulatory guidance. The Best Practices document provides a risk-based, end-to-end development strategy to support informed decision-making across seven essential areas.
Dan Devers joins the Stowers Institute with over 20 years of experience in law and business. He will lead all legal matters across the Institute, ensuring governance, compliance, intellectual property strategy, and partnerships support the Institute's mission to diagnose, treat, and prevent disease.
The Association for Molecular Pathology recognized Dr. Laposata's contributions to clinical laboratory practice and his role in challenging the FDA's rule on laboratory-developed test regulation. The award preserves diagnostic innovation, ensures patient access, and avoids escalating healthcare costs.
A combination of data from the FDA and independent studies confirms 7-OH's strong real-world safety profile, with no confirmed deaths reported despite over half a billion estimated doses consumed nationwide. The analysis also found that 7-OH has a significantly lower risk profile than many other natural compounds currently on the market.
GeniPhys has received FDA clearance for its self-assembling collagen scaffold, Collymer Self-Assembling Scaffold (SAS), which supports cellular infiltration and vascularization. The technology is indicated for various wound types and anchors a growing intellectual property portfolio with nearly 20 issued or pending patents.
A new study highlights major hurdles for multinational clinical trials in Europe, including differences in timelines and processing times between countries. Researchers found that the UK made significant gains in efficiency during the pandemic, while non-UK countries lagged behind.
A study by Carnegie Mellon University researchers found that regulatory firms may underperform due to ingroup bias, favoring domestic clients over foreign ones. However, inspectors' professionalism reduces this bias, leading to more uniform enforcement of regulations across entities.
A new study reveals that consumers place a higher value on products from circular economies due to the concept of psychological ownership. This finding suggests that businesses and policymakers can align strategies with consumer values to promote sustainable initiatives.
The FDA approved brexpiprazole, an antipsychotic drug, for treating agitation in elderly patients with dementia, despite trials showing it failed to provide a clinically meaningful benefit and increased the risk of death. The decision may reverse efforts to reduce off-label use of antipsychotics in care homes.
The International Vaccine Institute (IVI) has launched a two-week training course for biologics development and manufacturing, targeting low- and middle-income countries. The program aims to enhance local production of vaccines and biologics in LMICs to address vaccine inequity and global pandemic preparedness.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have applied a similar mindset when advising live biotherapeutic product developer YSOPIA Bioscience. This collaboration has provided valuable regulatory feedback for the company's clinical development efforts. The review highlights the need for harmonize...
The Yale School of Public Health is partnering with Tevogen Bio to expand its regulatory sciences program, with financial support from the biotech company. The goal is to prepare talented leaders for a rapidly growing field that focuses on product regulation and assessment.
The FDA is considering new rules to speed up confirmatory trials of drugs granted accelerated approval, following a review that found six indications remained on the market without confirmation. The median time between accelerated and regular approval was 3.9 years, with some drugs remaining on the market for over 10 years.
TGen Drug Development and Rondaxe Enterprises announce a strategic alliance to help emerging companies bring high-quality treatments to market. The partnership focuses on maximizing value proposition through drug development and manufacturing strategies, bridging the gap between chemistry and translational medicine.
A lack of standard definition hinders efforts to regulate predatory lending practices, which target borrower vulnerabilities and involve excessive lending beyond affordable capacity. Researchers recommend strengthening industry standards through legal action and self-regulation.
The article argues that guaranteed renewability pools risk and protects consumers from price increases without resorting to heavy regulation of the market or reduced consumer choice. It also prevents adverse selection by preventing those who know they are likely to get sick from buying more generous coverage.