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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

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. The rest of this blog will focus on the Clinical Trials Grants Program. By Sarah Wicks & James E. Valentine — The U.S. Relative to other areas of medicine (e.g.,

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FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. 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.

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Time for change: non-human primates in drug research

Drug Target Review

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. 3-5 These layers of regulation, while essential for animal welfare, make NHP-based studies complex, expensive and time-consuming.

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Microbiological Applications: Bacterial Metabolism | BMG LABTECH

BMG Labtech

These applications are incredibly useful for basic research, studying the environment , probing different aspects of biotechnology , or contributing to undertakings like drug discovery. Improved understanding Understanding metabolism is also crucial for drug discovery and investigating disease mechanisms.

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The CMC Perspective on Inhaled Combination Product Development

The Premier Consulting Blog

Inhalation offers a targeted route of drug delivery directly to the lungs, minimizing systemic side effects and maximizing therapeutic benefits. Reduced side effects: ICPs can offer reduced side effects compared to individual drugs because a lower dose of each drug is often sufficient when they are combined.

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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 a company applies these approaches, even small or novice drug developers will see increased efficiency.

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials. Tobolowsky & Charles G. Raver & James E.

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