FDA’s
Center for Drug Evaluation and Research (CDER) has embarked on an initiative to
modernize the New Drugs Regulatory Program. This effort will allow CDER to
better serve patients and better support staff in their work to carry out the
center’s mission – to protect and promote health by making sure that human
drugs are safe and effective for their intended use, that they meet established
quality standards, and that they are available to patients.
The
modernization of the New Drugs Regulatory Program will be a long-term process
of continuous improvement involving multiple initiatives. The modernization
focuses on six strategic objectives:
Scientific
Leadership
Grow
our scientific expertise and clarify pathways to regulatory approval.
Scientific
leadership is vital for our ongoing success. Addressing unmet medical needs is
an important part of our public health mission. As such, we aspire to expand
our scientific expertise to enable better regulatory decisions. We will
continue to hire talented scientists, work to develop long-term career paths
for them, so they can become our next generation of seasoned leaders. We will
proactively collaborate with academic medical scientists and patient/disease
advocates, provide scientific vision and direction, and strategically foster
drug development.
Integrated
Assessment
Critically,
collaboratively, and consistently assess whether information in drug approval
applications meets legal and regulatory requirements.
We are
implementing a new process with early identification and focus on the important
application-specific issues, uses a team-based interdisciplinary model, and
increasingly incorporates the patient perspective, providing an integrated
assessment.
Benefit-Risk
Monitoring
Systematically
monitor the benefits and risks of approved drugs pre- and post- approval to
effectively protect the American public.
Ensuring safety of
all drugs remains a key component of our mission and our new plans. We will work to establish a unified
post-market safety surveillance framework to monitor the benefits and risks of
drugs across their lifecycles, both before and after approval.
Managing
Talent
Attract,
develop, and retain outstanding people.
We will use
various hiring mechanisms such as 21st Century Cures Act pay authorities to
enhance our efforts to retain our current talented staff and attract and
recruit future talented staff for the New Drugs Regulatory Program, assuring
the next generation of leaders.
Operational
Excellence
Standardize
workflow, business processes, roles, and responsibilities to improve
operational efficiency, and enable our scientists to focus on science.
As part of the
proposed organizational structure changes within the Office of New Drugs (OND),
we plan to standardize various regulatory and business processes. Our proposed
organizational structure creates a central office of regulatory, program and
administrative operations servicing all of OND. Our aim is to enable our
scientific and clinical experts to focus on what they know best – science and
medicine – and allow our regulatory and administrative experts to manage the
many processes we conduct.
Knowledge
Management
Facilitate
the identification, capture, distribution and effective use of information.
Knowledge
management is essential to leverage the data we receive from outside sources as
well as what we generate from within the FDA. Vast and diverse information is
submitted to and generated by the New Drugs Regulatory Program. We plan to
markedly expand knowledge management capabilities, which will allow us to
better retrieve and utilize information that will improve decision-making and
accountability.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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