Examples of Clinical Hold in a sentence
Refer to SOPP 8201, “Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications” (Ref.
Manual of Standard Operating Procedures and Policies Investigational New Drug; Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications, SOPP 8201, Version #3, April 27, 1999, http://www.fda.gov/cber/regsopp/8201.htm.
Form FDA 3926 may also be used for certain follow-up submissions to an individual patient expanded access IND, which include the following: Initial Written IND Safety Report(§ 312.32(c)); Follow-up to a Written IND Safety Report (§ 312.32(d)); Annual Report(§ 312.33); Summary of Expanded Access Use (treatment completed) (§ 312.310(c)(2)); Change in Treatment Plan (§ 312.30); General Correspondence or Response to FDA Request for Information (§ 312.41); and Response to Clinical Hold (§ 312.42(e)).
For a further description of "On Clinical Hold," see "-- Products and Products Under Development -- Autoimmune and Inflammatory Products -- PRIMATIZED IDEC-151 and IDEC-CE9.1. (2) Although Phase I trials have been completed, the Company does not intend to pursue further development unless and until it enters into a partnering arrangement for such development.
A SIR should include clear, specific questions regarding review issues relevant to the planned response to the pending marketing submission hold letter (e.g., questions regarding non-clinical and clinical testing protocols or data needed to support the submission), IND Clinical Hold, or IDE letter, including identification of the deficiencies to be discussed, in order to focus FDA and submitter efforts on issues most relevant to moving a project forward.