Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Changes to an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA)

Streszczenie

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Changes to an ``Approved NDA or ANDA'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA).