Investigator Initiated Trials
At Allergan, we are committed to supporting Investigator Initiated Trials (IITs) as a part of the drug discovery and development process. Scientific research produced by qualified third party investigators is key to complementing Allergan-sponsored research to help better understand the benefit/risk profile of our therapies as well as explore new opportunities to address unmet medical needs.
We define IITs as studies developed and sponsored by an independent investigator or academic sponsor. We require that clinical research undertaken through IITs be based on the need to address meaningful scientific and/or clinical objectives supported by valid scientific designs while respecting the privacy rights, safety and welfare of patients.
An IIT may be either a clinical or non-clinical study, conducted without the participation of Allergan for which the sponsor has requested that Allergan provide funding, drug product or both. We provide financial support and/or drug product for IITs according to a written agreement, which requires that third-party sponsors comply with applicable local laws and regulatory requirements.
Post Marketing Commitments
Post Marketing Commitments (PMCs) and Post Marketing Requirements (PMRs) are studies and clinical trials conducted by a sponsor after the Food and Drug Administration (FDA) has approved a drug or biological product. The studies/trials are designed to generate additional information about the product’s safety, efficacy, or optimal use. PMCs are studies or trials a sponsor has agreed with FDA to conduct; they are not required by statute or regulation. PMRs are studies or trials that sponsors are required to conduct post-approval according to statute or regulation.
2020欧洲杯体育投注网址 Allergan is subject to PMCs and PMRs covering a range of studies/trials in various stages of development. Information about Allergan's post marketing commitments is believed to be correct at the time that the information is posted, and is subject to change as progress is made in fulfilling the commitments.