Understanding Regulatory and Market Access Considerations With Drug Abuse Potential

Each assessment for abuse liability is as unique as the molecule in question, reiterating Regulatory And Market Access Considerations With Drug Abuse Potentialthe importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly.

In our previous blog post, we focused on the value of early drug abuse potential testing. In this blog, we’ll delve into important regulatory and market access considerations for abuse liability testing that can help drug developers maximize the potential of their molecule.

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The Next Frontier for Cancer Immunotherapy Trials

With its measurable impact on patient survival, there’s no denying that immunotherapy is Cancer Immunotherapy Trialsalready causing momentum in ways that cancer is treated. Drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.

With checkpoint inhibitors from ipilimumab (Yervoy®) to nivolumab (Opdivo®) to pembrolizumab (Keytruda®) to the most recently approved atezolizumab (TecentriqTM), each breakthrough has provided new insights on how the immune system can be activated and manipulated to fight a variety of cancers. Continue reading

New FDA Labeling Regulations are Here – Are you Prepared?

The new FDA regulations for the Nutrition Facts labels and Supplement Facts labels went Covance FDA Regulations Nutrition Food Solutionsinto effect this month. With a refreshed design reflecting updated information about nutrition science, the new label is intended to better inform consumers about their choices.

While manufacturers have two or up to three years to revise or correct their product labels, we’ve seen many proactive companies consider the impact of these regulations on their future ingredients, processes and claims.

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Understanding 505(b)(2): An Abbreviated Pathway for Modified Drugs

Among the regulatory pathways for small molecule drugs in the United States, the 505(b)(2) option occupies a middle ground. Intended for modifications of an existing505(b)(2): An Abbreviated Pathway for Modified Drugs Covance Blog treatment, it requires much more evidence than a generic but allows the sponsor to use data from a previous application. Companies can thus avoid unnecessarily repeating studies and shorten their development time.

At a recent Covance clinical seminar in Shanghai, attendees learned about the intricacies of 505(b)(2), the corresponding hybrid medicinal product pathway in the European Union and the differences from applications for biosimilars or generics. Developers in the Asia Pacific region are eager to better understand this topic because the Chinese pharmaceutical industry is developing rapidly with support from the government. “They view 505(b)(2) as a potentially faster way to market,” said Eric Lang, MD, Vice President and Global Head of Clinical Drug Development Leaders, Early Phase Development Solutions. To succeed, however, sponsors will need to consult with experts who can help them develop a regulatory strategy and consider market access issues as well. Continue reading

Developing a Successful Regulatory Strategy for Mobile Health Devices and Applications

For many technology companies entering the mobile health space, meeting US Food and Drug Administration (FDA) requirements may be unfamiliar territory. The Covance Mobile Health Blogguidelines can appear convoluted and contradictory at first glance, and some devices and/or applications (apps) fall into regulatory grey areas.

To make progress in this rapidly changing field, companies need to find a way to work within the regulations while encouraging creative development. Consulting with experts and the FDA, considering key design issues, taking precautionary quality measures and assessing global requirements will increase the chances that a company can bring a safe and successful mobile health device and/or app to market.

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FDA Takes Final Step On Manufacturing Standards of Infant Formula

FDA Takes Final Step On Manufacturing Standards of Infant FormulaAn estimated 1 million infants in the U.S. are fed formula from birth, and by the time they are three months old, about 2.7 million rely on formula for at least part of their nutrition.

On June 9, 2014 the U.S. Food and Drug Administration released a final rule regarding the manufacturing standards of infant formula. The final rule—which amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufactures of infant formulas—is meant to ensure that formulas for infants without unusual medical or dietary problems are safe and support healthy growth. The rule also establishes current good manufacturing practices (CGMPs), and sets a date of September 8, 2014 for manufacturer compliance. Continue reading

Shaping Global Standards for Bioanalysis

Global Bioanalysis ConsortiumWhen we provide sample concentration data for submission with new drug applications, clients have an expectation that those data will meet regulatory agency expectations for quality, accuracy, and precision. Those expectations have been evolving since the first US consensus AAPS/FDA workshop (Crystal City I) in 1990. Subsequent workshops and the resulting white papers have formed the basis for guidance documents on conducting method validations and sample analysis. These documents are published by regulatory agencies such as the US FDA and the European Medicines Agency. Continue reading