Bioequivalency Compliance Development 
Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Still, navigating such patent issues during drug development can be difficult, and Camargo can assist in finding a safe course. Ken Phelps.
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Generic Drug Development To market a generic drug in Japan, an ANDA must be submitted to the PMDA. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.
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Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. This article will delve into the importance of scientific expertise in generic drug development, highlighting the key areas where scientific knowledge is essential.
XTalks
NOVEMBER 6, 2024
The gel’s formulation tackles common challenges in medication compliance by improving taste, reducing choking risk and enabling easier swallowing, especially for individuals with dysphagia or populations with specific dietary or swallowing needs, such as children and seniors.
Camargo
DECEMBER 22, 2021
Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Biowaiver Eligibility.
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.
FDA Law Blog
JUNE 10, 2024
It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.
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