FDA Policy/General

CVM Electronic Submission Registration

FDA has published a guidance, Registering with CVM’s Electronic Submission System, with general standards that the agency says should be used to register with the Center’s electronic submission system (ESS). The document says CVM’s ability to receive and process information submitted electronically is limited by its current information technology capabilities and the requirements of FDA’s Electronic Records; Electronic Signatures Regulation.

The guidance implements provisions of the Government Paperwork Elimination Act of 1998 that require executive agencies to provide for (1) the option of the electronic maintenance, submission, or disclosure of information, if practicable, as a substitute for paper, and (2) the use and acceptance of electronic signatures when practicable, both by 10/21.

The guidance contents are an Introduction, Communication Between CVM and Stakeholders, Registering with the CVM Electronic Submission System, Processing Procedures for Electronic Submissions, Security Measures for Electronic Submissions, Checklist for Registering with the CVM ESS, Help, and three Appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome