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| Mixing, Diluting, or Repackiaging Biological Products Outside the Scope of an Approved Biologics | |||
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| 분류 | GMP, Guidance | 조회 | 3147 |
| 발행년도 | 2015 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guidance sets forth FDA’s policy regarding the mixing, diluting, and repackaging of certain types of biological products that have been licensed under section 351 of the Public Health Service Act (PHS Act) when such activities are not within the scope of the product’s approved biologics license application (BLA) as described in the approved labeling for the product.
(후략)
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 이전글 |
Current Good Manufacturing Practice Requirements for Combination Products |
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 다음글 |
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities |
