Telephone/Fax Amendments Are "Highest Priority" For ANDA Reviewers
This article was originally published in The Tan Sheet
Telephone and facsimile ANDA amendments will be designated as "highest priority" by FDA reviewers, the agency says in its recent guidance on "Major, Minor, Fax and Telephone Amendments to Original Abbreviated New Drug Applications."
You may also be interested in...
FDA's Office of Generic Drugs estimates it could approve or tentatively approve 315 generic drug applications in calendar year 2000, a 30% increase from 1999.
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