ANDA fax amendments
This article was originally published in The Tan Sheet
Executive Summary
Guidance for industry on ANDA amendments modified to include faxed amendments among those that would stop the agency's review clock. Under its August 1999 version of the guidance, fax and telephone amendments did not affect the Office of Generic Drugs' review process. "The issuance of major, minor and fax amendments stops the review clock while the applicant addresses deficiencies noted by OGD, but telephone amendments do not stop the clock unless the applicant does not respond within the anticipated time"
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
People In Brief
Perrigo promotes in pricing, planning
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC