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A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
Working Group II (founded 1992): International Reporting of Periodic Drug-Safety Update Summaries Working Group III (founded 1995): Guidelines for Preparing Core Clinical-Safety Information on Drugs Working Group IV (founded 1998): Benefit-Risk Balance for Marketed Drugs: Evaluation of Safety Signals
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety program, allocate more resources for television advertising, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers. [4]
In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
Drug products compounded by or under the direct supervision of a licensed pharmacist at an outsourcing facility may be able to qualify for exemptions from the following three sections of the FD&C Act: (1) section 505 (concerning FDA approval of drugs); (2) section 502(f)(1) (concerning the labeling of drug products with adequate directions for ...
The first appearance of the term ‘safety pharmacology’ in the published literature dates back to 1980. [5] The term was certainly in common usage in the 1980s within the pharmaceutical industry to describe nonclinical pharmacological evaluation of unintended effects of candidate drugs for regulatory submissions. [6]
Pharmacogenomics is also known as companion diagnostics, meaning tests being bundled with drugs. Examples include KRAS test with cetuximab and EGFR test with gefitinib . Beside efficacy, germline pharmacogenetics can help to identify patients likely to undergo severe toxicities when given cytotoxics showing impaired detoxification in relation ...
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