Bioequivalency Compliance Marketing 
Drug Patent Watch
DECEMBER 30, 2024
This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. New Drug Application (NDA) : Needed for marketing approval of new drugs.
Camargo
NOVEMBER 11, 2020
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.
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Camargo
DECEMBER 22, 2021
In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence.
Drug Patent Watch
DECEMBER 12, 2024
This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. Understanding the Pharmaceutical Market Dynamics The pharmaceutical industry is a complex ecosystem where branded drugs and generics coexist, each playing a vital role in patient care and market dynamics.
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.
FDA Law Blog
NOVEMBER 6, 2023
In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months. The current and earlier guidances note that declining an RIE may delay regulatory decisions, such as approvals of applications for marketing authorization.
Drug Patent Watch
DECEMBER 10, 2024
These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory agencies also conduct inspections and audits to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines.
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