BIO Submits Comments to FDA on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
March 14, 2017
BIO submitted comments on the Food and Drug Administration’s draft guidance, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance for Industry.
BIO is committed to the effort to protect patients when biological products are handled in a manner that is inconsistent with their approved labeling and could result in contamination or a lack of effectiveness. BIO supports the FDA's efforts to release this draft guidance.
However, BIO believes some issues with respect to mixed, diluted, and repackaged biologics are not appropriately addressed in draft guidance or would benefit from additional clarification or refinement – such as the criticality of ensuring the sterility of the biological product’s primary container closure and its secondary packaging, which is essential to patient safety.
Download Full Comments Below
2017-3-14-17 BIO Comments On Revised Compounding Outside BLA FINAL
We, the undersigned, are writing to express our strong concern with a proposed update to the Medicaid Drug Rebate Program. If finalized in its current form, the proposed rule (CMS-2434-P) would impose significant costs to the government and industry…
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Senate Committee on Health, Education, Labor, and Pensions’ (Committee’s) Request for Information on Improving and Protecting Access to Gene Therapies…
BIO submitted comments on the Food and Drug Administration’s draft guidance, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance for Industry.
BIO is committed to the effort to protect patients when biological products are handled in a manner that is inconsistent with their approved labeling and could result in contamination or a lack of effectiveness. BIO supports the FDA's efforts to release this draft guidance.
However, BIO believes some issues with respect to mixed, diluted, and repackaged biologics are not appropriately addressed in draft guidance or would benefit from additional clarification or refinement – such as the criticality of ensuring the sterility of the biological product’s primary container closure and its secondary packaging, which is essential to patient safety.