Number two: prepare for the pre-IND meeting well in advance. Keep in mind that this meeting is the first glimpse that FDA will have of the proposed product, and the meeting will set the tone for future interactions—the importance of making a good first impression cannot be overstated. It ...
The notable exceptions are password fields, which only the IND570 System modules may read. Hard-coding in Shared Data restricts read-access to the password fields. The Shared Data Dictionary defines the write-access privileges on an individual field basis, according to the class of the user. ...
This includes the counties, codes of US federal regulations, IND sections plus various modules and notable guidance for industry by FDA.Khojasteh, S. CyrusGenentech, Inc.Wong, HarveyUniversity of British ColumbiaZhang, DongluGenentech, Inc.Hop, Cornelis E.C.A.Genentech, Inc....
一型:制剂药厂相关信息,由成品制剂企业呈交;2000后,FDA不再接受一型DMF。 二型:主要为原料药相关信息,由原料药企业呈交(有时原料药企业即为相应制剂企业);IND申报资料通常在 这一类中。 三型:包装材料信息。 四型:药用辅料信息。 五型:其他;在具有清晰的理由下,需事先沟通得到FDA的认可后才能被接受。对于非...