jueves, 8 de marzo de 2018

What's New in Regulatory Science

Spotlight on CDER Science

CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals

Using state of the art laboratory platforms, CDER researchers are studying several advanced manufacturing technologies, including 3-dimensional (3D) printing. Recent advances in 3D printing (often referred to as additive manufacturing) highlight its tremendous potential to produce drug products that are exquisitely tailored (for example in their dosage and delivery forms) to the needs of an individual patient. Click here for more information on how CDER is advancing our basic understanding of 3D printing processes, and developing evaluative methods that can foster development of drug products manufactured with this technology.
Developing a Regulatory Framework to Evaluate Real World Evidence in Drug Development

Real world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real world data obtained outside the clinical study setting. Under the 21st Century Cures Act,  FDA is directed to develop a regulatory framework to evaluate how RWE can be used to support approval of new indications for approved drugs or help fulfill post-approval study requirements.
FDA currently accepts RWE to support regulatory decision-making about drug safety and is seeking stakeholder input in identifying promising areas for pilot demonstrations and innovative methods for deriving RWE. FDA continues to engage industry, patients, patient advocacy organizations, and others stakeholders to address key issues such as standardizing nomenclature, and methodological considerations for data collection, reporting, and analysis.

The National Academies of Science Engineering Medicine (NASEM) has coordinated a series of workshops titled “Examining the Impact of Real World Evidence on Medical Product Development.” Material from workshop I in this series, “Incentives,” is available on the NASEM website.  Workshop III, focusing on operationalizing the collection and use of real-world evidence, is scheduled for July 2018.
Generic Drugs Science and Research 
The Office of Research and Standards, a sub-office of the Office of Generic Drugs, supports the regulatory science program established under the Generic Drug User Fee Amendments (GDUFA). As part of their ongoing work to make FDA’s Generic Drugs program efforts more accessible to the public, OGD has expanded its Science & Research web presence to provide more intuitive navigation and easily digestible content. Information includes priorities and projects, research publications and resources, guidances and reports, collaboration opportunities, and generic drugs science and research news. Click here to view the new web pages.
The revised Generic Drugs webpage launched in September 2017. These changes offer site visitors easy access to information, whether they are patients, industry, reporters, researchers, or healthcare providers.


March 2018
  • Public Meeting: Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Drug Development, March 19, 2018.  Meeting Information
  • Promoting the Use of Complex Innovative Designs in Clinical Trials, March 20, 2018. Meeting Information 
April 2018
  • Public workshop: CDER and You: Keys to Effective Engagement, April 3, 2018. Meeting information 
  • Public Meeting: Patient-Focused Drug Development for Opioid Use Disorder, April 17, 2018. Meeting information
May 2018
  • FY 2018 Generic Drug Research Public Workshop, Thursday, May 24, 2018.  Meeting Information


CDER Summer Research Participation Program 2018 (Paid Internship Opportunity)

This summer program, administered under the auspices of the Oak Ridge Institute for Science and Education (ORISE), is an opportunity for participants to engage with mentors, and examine questions on topics relevant to the CDER’s needs, gaining hands-on experience on regulatory research projects under expert mentors. Interns will work at CDER’s White Oak Campus, Silver Spring, MD.

Application deadlines vary by placement office. For more information on CDER opportunities, click hereand search “CDER summer.”

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