Biopharmaceutical Manufacturing and Distribution

March 18, 2014

While BIO does not comment on individual companies or their decision-making in regards to...

May 21, 2011

The number of Americans diagnosed with diabetes — the seventh leading cause of death in...

May 9, 2011

Soelkner discusses the benefits of working with a contract manufacturing organization and how...

April 8, 2011

BIOtechNOW talks to GEN's John Sterling regarding the upcoming BIO International...

Letters, Testimony & Comments

February 16 2016
BIO supports FDA’s assertion that “it is critical for sponsors to detect and report, as early as possible, serious and unexpected suspected adverse reactions and clinically important increased rates of previously recognized serious adverse reactions,” and we appreciate the publication of this Draft Guidance to aid Sponsors in this responsibility. However, we are concerned about the prescriptive nature of this Draft Guidance and its emphasis on the Safety Assessment Committee (SAC). We are also concerned that FDA may not fully appreciate the time and resources required of Sponsors to implement the recommendations within the Draft Guidance.
November 24 2015
In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.
July 30 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).
July 30 2015
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).
May 19 2015
BIO applauds the issuance by the Food and Drug Administration (FDA) of the Draft Guidance entitled, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” (Draft Guidance)1 The policies and recommendations set forth in the Draft Guidance, when finalized, represent critical steps forward in the effort to protect patients from biological products prepared under conditions that could result in their contamination or a lack of effectiveness.

Press Releases

May 24 2013
Rx Response elevates to Alert status to address potential impact from Moore tornado on supply chain.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
June 28 2011
BIO announced its endorsement of the “Joint Declaration on Cooperation in the Fight against Doping in Sport” between the World Anti-Doping Agency (WADA) and the International Federation of Pharmaceutical Manufactures and Associations (IFPMA).
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.