Office of Clinical Pharmacology | FDA - U.S. Food and Drug …

The mission of the Office of Clinical Pharmacology is two-fold: 1) play a pivotal role in advancing development of innovative new medicines by applying state-of-the-art scientific principles; and ...

FAQs about Office of Clinical Pharmacology | FDA - U.S. Food and Drug … Coupon?

What is Clinical Pharmacology?

Clinical pharmacology is a multidisciplinary science, and our reviews synthesize information from all relevant clinical pharmacology knowledge areas including drug disposition, pharmacology and biomarkers, quantitative methods, drug safety, pharmacotherapy, and clinical trial methods. ...

What is a clinical pharmacology review?

The clinical pharmacology review is issue-driven, and the information in the application for a new drug or biologic is assessed to address important issues of dose selection and optimization, therapeutic individualization, and benefit-risk (including application in subpopulations) (12). ...

What is Clinical Pharmacology corner?

Our Clinical Pharmacology Corner subscription service reaching over 95,000 stakeholders will deploy enhanced formats for disseminating information on notable updates and new drug approvals, and new free subscription services dedicated to quantitative and translational sciences are in the works. ...

How many clinical pharmacology guidances did OCP issue in 2019?

In 2019, OCP issued six clinical pharmacology guidances (4 – 9) and contributed to 24 multidisciplinary guidances on broad drug development topics. Each published guidance is the product of years of regulatory research and represents the agency’s current thinking on a particular subject. ...

Why is Clinical Pharmacology important?

Continued advances in clinical pharmacology can be the basis of more rational and efficient drug development and improved access to new drug treatments that are tailored to the patient to achieve better efficacy and safety. KEY WORDS: clinical pharmacology, regulatory science, precision medicine, drug development ...

How pharmacology advice is conveyed?

The advice is conveyed during FDA-sponsor meetings and/or in written responses. In addition, formal guidance documents are developed to assist drug developers. In 2019, OCP issued six clinical pharmacology guidances (4 – 9) and contributed to 24 multidisciplinary guidances on broad drug development topics. ...