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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

The rest of this blog will focus on the Clinical Trials Grants Program. These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development.

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FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

In this blog, we explore the concept of advanced manufacturing and outline the FDA programs that play a critical role in promoting innovation while ensuring product quality. What is advanced manufacturing? Contact us today to find out how we can support your program.

FDA
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Microbiological Applications: Bacterial Metabolism | BMG LABTECH

BMG Labtech

1-3 In this blog we examine bacterial metabolism: its scope, its interest to researchers, and how diverse applications, including those linked to metabolic control, measurement of metabolites and bacterial growth, can be determined using microplate readers. 9) and the bioluminescence arising from quorum sensing in parallel.

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The CMC Perspective on Inhaled Combination Product Development

The Premier Consulting Blog

In this blog, we will discuss what a combination product is, why there is a particular advantage for inhaled products, and regulatory factors that apply to CMC activities. What is a combination product? ICPs are subject to rigorous regulatory scrutiny due to their complexity.

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Winning Regulatory Trust: Six Smart Strategies for Emerging Biotechs

PPD

When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines. When teams are well prepared ahead of time, it builds credibility with regulators, and credibility is a valuable currency in the regulatory approval process.

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.

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Time for change: non-human primates in drug research

Drug Target Review

3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming. However, the last decade has seen a gradual reduction in their use, driven by tightening animal welfare regulations and scientific advances. Are we nearing a post-NHP future? Toxicology Research.