Clinical Operations-Design to Execution

BayBiotech.NET Electronic Common Technical Document (eCTD) is an ICH standard adopted by FDA as a member of ICH, together with other member regions, Europe & Japan to facilitate electronic submissions to the agency. Harmonization of guidelines has been done to achieve global consistency in order to facilitate globalization of the drug discovery efforts. As of 2008, eCTD standard is the only acceptable format for new electronic submissions to the agency with an exceptions for submissions that are already under review. As the agency is working to standardize the eCTD process, it is encouraging the Industry to begin working on establishing a system for eCTD submissions. It is advisable to either use an in-house developed or commercially purchased e-CTD tool. In order to validate your eCTD tool, it will be important to pay attention to the following major issues identified by the agency regarding the eCTD submissions: 1. Lack of 356h, 1571, or 2252 forms in a submission. 2. Lac...

BayBiotech.NET Orphan Drug is a special status designated to a drug or biologics to treat a rare disease or condition. In order to obtain this designation, drug or biologics must meet certain criteria. Orphan designation qualifies the sponsor for the tax credit and marketing incentives as per Orphan Drug Act. In addition, orphan drug is not subject to a prescription drug user fee unless used for other indications. For application purposes, sponsor shall submit two copies of a completed, dated, and signed request for designation that contains the following: (1) A statement that the sponsor requests orphan drug designation for a rare disease or condition. (2) The name and address of the sponsor; the name of the sponsor's primary contact person. (3) A description of the rare disease or condition for which the drug will be investigated. (4) A scientific rationale for the use of the drug for the rare disease or condition. (5) Where the sponsor of an already approved orp...