Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile (US Food and Drug Administration Regulation) (FDA) (2018 Edition)

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the appropriate FDA Center Director may grant an exception or alternative to such labeling requirements if he or she determines that compliance with the requirements could adversely affect the safety, effectiveness, or availability of specified lots, batches, or other units of human drugs, biological products, or medical devices that are or will be included in the SNS, including not only those that are approved, licensed, or cleared for marketing, but also those that are investigational. A grant of an exception or alternative under these regulations will include any safeguards or conditions deemed appropriate by the FDA Center Director to ensure that the labeling of such products includes information for the safe and effective use of the products given their anticipated circumstances of use. This rule will facilitate the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency. This book contains: - The complete text of the Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section