FDA Amends Drug Shortage Regulations

Read the full text final rule: Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

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WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group

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View the article with multiple links:  GMP News: WHO publishes interesting new Guidance for the Storage and Transport of Pharmaceutical Products - GDP Group, an ECA Foundation Interest Group:

"For those working in the area of Good Distribution Practice (GDP) the following paper might be interesting: Technical supplements to Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products."

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