News from the FDA

Effective Sept. 20, 2004, civil money penalties for a number of infractions over which the FDA has jurisdiction will increase, in accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. For further information, go to: http://a257.g.aka maitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16388.htm

Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications

The FDA proposes to amend its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs by discontinuing the use of approvable letters and not approvable letters when taking action on marketing applications. Instead, the agency would issue complete response letters to indicate that the review cycle is complete and that the application is not ready for approval. It is also proposing to revise the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new cycle after a resubmission following receipt of a complete response letter. Finally, the FDA is proposing to add to the regulations on biologics license applications (BLAs) a provision on the issuance of complete response letters to BLA applicants. These actions are being taken to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 that address procedures and establish target timeframes for reviewing human drug applications.

You may submit comments, identified by Docket No. 2004N-0267, by any of the following methods:

1) Federal eRulemaking Portal: http://www.regulations.gov (follow the instructions for submitting comments); 2) Agency Web Site: http://www.fda.gov/dockets/ecomments (follow the instructions for submitting comments on the agency Web site); 3) E-mail: [email protected] (include Docket No. 2004N-0267 in the subject line of your e-mail message.) For further information, see: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16476.htm. .

FDA to Establish New Cancer Office and Program

A new Office of Oncology Drug Products (ODP), will be housed in the Center for Drug Evaluation and Research (CDER), and will be a consolidation of three existing areas within CDER responsible for the review of drugs and therapeutic biologics used to diagnose, treat, and prevent cancer. The FDA announced these plans on July 16, changing its organizational structure to provide for a stronger and more consistent approach to the review process for drugs and most therapeutic biologics used to diagnose, treat, and prevent cancer. This new office will monitor drugs and certain therapeutic biologics used in medical imaging, many of which are used to detect, treat, or monitor cancer. It is hoped that the creation of this new office will improve consistency of review and policy toward oncology drugs, and bring together a critical mass of oncologists who will help develop new therapies. A national search to recruit a director for the new office will begin later this summer.

Medical Devices: A Proposed Globally Harmonized Alternative for Premarket Procedures

The FDA has revised the final guidance titled, “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff” by extending the voluntary pilot premarket review program by 1 year. The document seeks to harmonize the different requirements for premarket submissions in various countries. The extension of time for the pilot program is intended to reduce the burden on manufacturers who face conflicting premarket submission format and content requirements in different countries. The pilot program will evaluate whether an alternative submission procedure, as described in the document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices” is the best alternative.

For more information, see: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16825.htm. .

Botox Approved to Treat Severe Underarm Sweating

Botox (Botulinum Toxin Type A), the substance so popular today for smoothing out facial lines, was approved in July by the FDA to treat severe underarm sweating known as “primary axillary hyperhidrosis” that cannot be managed by topical agents such as prescription antiperspirants. The most common adverse events following treatment (occurring in 3% to 10% of patients) included injection site pain and hemorrhage, sweating in other parts of the body, flu-like symptoms, headache, fever, itching, and anxiety.

New Director Named to Lead Center for Devices and Radiological Health

Acting FDA Commissioner Dr. Lester M. Crawford announced on July 20 that Daniel G. Schultz, M.D., will lead the agency's Center for Devices and Radiological Health (CDRH). In that capacity, Dr. Schultz will be responsible for FDA's review of all medical devices, as well as radiation-emitting products such as magnetic resonance imaging equipment and X-ray machines.

Civil Money Penalties to Be Increased

Effective Sept. 20, 2004, civil money penalties for a number of infractions over which the FDA has jurisdiction will increase, in accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. For further information, go to: http://a257.g.aka maitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16388.htm

Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications

The FDA proposes to amend its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs by discontinuing the use of approvable letters and not approvable letters when taking action on marketing applications. Instead, the agency would issue complete response letters to indicate that the review cycle is complete and that the application is not ready for approval. It is also proposing to revise the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new cycle after a resubmission following receipt of a complete response letter. Finally, the FDA is proposing to add to the regulations on biologics license applications (BLAs) a provision on the issuance of complete response letters to BLA applicants. These actions are being taken to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 that address procedures and establish target timeframes for reviewing human drug applications.

You may submit comments, identified by Docket No. 2004N-0267, by any of the following methods:

1) Federal eRulemaking Portal: http://www.regulations.gov (follow the instructions for submitting comments); 2) Agency Web Site: http://www.fda.gov/dockets/ecomments (follow the instructions for submitting comments on the agency Web site); 3) E-mail: [email protected] (include Docket No. 2004N-0267 in the subject line of your e-mail message.) For further information, see: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16476.htm. .

FDA to Establish New Cancer Office and Program

A new Office of Oncology Drug Products (ODP), will be housed in the Center for Drug Evaluation and Research (CDER), and will be a consolidation of three existing areas within CDER responsible for the review of drugs and therapeutic biologics used to diagnose, treat, and prevent cancer. The FDA announced these plans on July 16, changing its organizational structure to provide for a stronger and more consistent approach to the review process for drugs and most therapeutic biologics used to diagnose, treat, and prevent cancer. This new office will monitor drugs and certain therapeutic biologics used in medical imaging, many of which are used to detect, treat, or monitor cancer. It is hoped that the creation of this new office will improve consistency of review and policy toward oncology drugs, and bring together a critical mass of oncologists who will help develop new therapies. A national search to recruit a director for the new office will begin later this summer.

Medical Devices: A Proposed Globally Harmonized Alternative for Premarket Procedures

The FDA has revised the final guidance titled, “A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff” by extending the voluntary pilot premarket review program by 1 year. The document seeks to harmonize the different requirements for premarket submissions in various countries. The extension of time for the pilot program is intended to reduce the burden on manufacturers who face conflicting premarket submission format and content requirements in different countries. The pilot program will evaluate whether an alternative submission procedure, as described in the document titled “Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices” is the best alternative.

For more information, see: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-16825.htm. .

Botox Approved to Treat Severe Underarm Sweating

Botox (Botulinum Toxin Type A), the substance so popular today for smoothing out facial lines, was approved in July by the FDA to treat severe underarm sweating known as “primary axillary hyperhidrosis” that cannot be managed by topical agents such as prescription antiperspirants. The most common adverse events following treatment (occurring in 3% to 10% of patients) included injection site pain and hemorrhage, sweating in other parts of the body, flu-like symptoms, headache, fever, itching, and anxiety.