News from the FDA

For further information, see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22183.htm.

Clarification on Electronic Records and Signatures Submitted to the FDA

A guidance for industry titled “Part 11, Electronic Records; Electronic Signatures – Scope and Application” is now available. The guidance explains FDA's current stance regarding the requirements and application of part 11, which sets out the criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures executed to electronic records.

The FDA published this guidance because concerns have been raised that some interpretations of the part 11 requirements would have the following effects: 1) Unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, 2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and 3) discourage innovation and technological advances without providing a significant public health benefit. These concerns have been raised particularly in the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems.

For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22574.htm.

FDA Seeks Comments on Anti-Counterfeit Drug Initiative

The FDA has established a docket to receive information and comments on the agency's initiative against counterfeit drugs. The agency encourages interested parties to submit information by November 30. Submit written comments and information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-21751.htm.

In a related announcement, the FDA has called a meeting to discuss its efforts to combat the manufacture, sale and distribution of counterfeit drugs. The FDA hopes to attract attendees who can give it information related to technology, public education and regulatory and legislative issues. Vendors of anti-counterfeit technologies are also invited to display their products at this event. The meeting, which is scheduled to take place October 15, will be at the Four Points Sheraton Bethesda, 8400 Wisconsin Ave., Bethesda, MD 20814, 301-654-1000. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22789.htm.

Meeting to Vote on Marketing of Silicone Breast Implants

The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet October 14 and 15 to discuss and vote on a pre-market approval application for silicone gel-filled breast implants. Background information, including the agenda and questions for the committee, will be available to the public October 10, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. For further information, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22580.htm.

Electronic Submissions Draft Guidance Available

“Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submission,” a draft guidance for industry, is one in a series of guidance documents on providing regulatory submissions to the FDA in electronic format. The guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics licensing applications (BLAs), investigational new drug applications (INDs), master files, advertising material, and promotional labeling. The agency predicts that submission of these documents in electronic format will improve its efficiency in processing, archiving, and reviewing them.

Submit written or electronic comments on the draft guidance by October 28 to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

For further information, see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22183.htm.

Clarification on Electronic Records and Signatures Submitted to the FDA

A guidance for industry titled “Part 11, Electronic Records; Electronic Signatures – Scope and Application” is now available. The guidance explains FDA's current stance regarding the requirements and application of part 11, which sets out the criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures executed to electronic records.

The FDA published this guidance because concerns have been raised that some interpretations of the part 11 requirements would have the following effects: 1) Unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA's stated intent in issuing the rule, 2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and 3) discourage innovation and technological advances without providing a significant public health benefit. These concerns have been raised particularly in the areas of part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems.

For further information, see: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22574.htm.

FDA Seeks Comments on Anti-Counterfeit Drug Initiative

The FDA has established a docket to receive information and comments on the agency's initiative against counterfeit drugs. The agency encourages interested parties to submit information by November 30. Submit written comments and information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-21751.htm.

In a related announcement, the FDA has called a meeting to discuss its efforts to combat the manufacture, sale and distribution of counterfeit drugs. The FDA hopes to attract attendees who can give it information related to technology, public education and regulatory and legislative issues. Vendors of anti-counterfeit technologies are also invited to display their products at this event. The meeting, which is scheduled to take place October 15, will be at the Four Points Sheraton Bethesda, 8400 Wisconsin Ave., Bethesda, MD 20814, 301-654-1000. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22789.htm.

Meeting to Vote on Marketing of Silicone Breast Implants

The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet October 14 and 15 to discuss and vote on a pre-market approval application for silicone gel-filled breast implants. Background information, including the agenda and questions for the committee, will be available to the public October 10, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. For further information, go to: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22580.htm.