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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? USDA (2020).

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Navigating Regulatory Hurdles in Drug Development

DrugBank

Drug development is a complex and highly regulated process. While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. Regulatory agencies, such as the U.S.

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Is Your In Vitro Diagnostic Exempt from Investigational Device Exemption Regulations?

The Premier Consulting Blog

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE. Available at [link]. [3]

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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog: Biosimilars

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. The “review phase” is the period between the initial submission and approval of the NADA. When the U.S. While Nissan et al.

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The Active Ingredient Stands Alone

FDA Law Blog: Biosimilars

As a result of the Biologics Price Competition and Innovation Act (BPCIA) passed in 2010, the definition of a “biological product” expanded to include “proteins.” To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy.

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New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

Nevertheless, in vitro models have important limitations, including the physiological changes the cells suffer when cultivated outside their organs of origin and the loss of the complex intercellular and hormonal communication and regulation present in body organs.

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Article Periodic Thank You What we expect EU regulators to do in February 2024

Agency IQ

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.