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Compounding: BIO Submits Comments to FDA on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

BIO Position on Proposals to Provide for Export Manufacturing Exemption during Patent Term Restoration

Export manufacturing exemptions weaken the IP protections afforded by Supplementary Protection Certificate and Patent Term Restoration.

Compounding: BIO Comments on FDA Draft Guidances on "Essentially Copies"

Re: Docket No. FDA-2016-D-1309: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act;...

Compounding: BIO Comments on FDA Draft Guidance nsanitary Conditions at Compounding Facilities

Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability ...

Compounding: BIO Comments on FDA Draft Guidance Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act

BIO applauds the issuance by the FDA of this Draft Guidance as it recognizes the importance of the prescription requirement under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). BIO recognizes that access to medically-needed compounded medicines is highly important; but access cannot and should not come at the expense of product quality and patient safety.

CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

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Quality Metrics: BIO Comments on FDA Draft Guidance Request for Quality Metrics

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.

BIO Comments on Established Conditions Reportable CMC Changes

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”).

BIO Comments on Established Conditions Reportable CMC Changes

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”).

BIO Comments on FDA Draft Guidance: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application

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.