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BIO submitted comments on the Food and Drug Administration’s draft guidance, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance for Industry.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 BIO supports the FDA's efforts to release this draft guidance.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BIO believes some issues with respect to mixed, diluted, and repackaged biologics are not appropriately addressed in draft guidance or would benefit from additional clarification or refinement – such as the criticality of ensuring the sterility of the biological product’s primary container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
Dear Colleagues,This month marks my one-year anniversary as BIO’s CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
BIO submitted comments on the Food and Drug Administration’s draft guidance, Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Revised Draft Guidance for Industry.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 BIO supports the FDA's efforts to release this draft guidance.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.