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BIO's comments to Health Resources and Services Administration (HRSA) on dispute resolution authorized in Section 7102 of the Patient Protection and Affordable Care Act

Nov 19 2010
The Biotechnology Industry Organization (“BIO”) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments (“ANPRM”) seeking to obtain information and public comment on how to efficiently and effectively implement the administrative process for dispute resolution authorized in Section 7102 of the Patient Protection and Affordable Care Act (“Affordable Care Act”), Pub. L. 111-148. See 75 Fed. Reg. 57,233 (Sept. 20, 2010).

BIO's comments to Health Resources and Services Administration (HRSA) on the Civil Monetary Penalties authority provided by Section 7102(a) of the Patient Protection and Affordable Care Act

Nov 19 2010
The Biotechnology Industry Organization (BIO) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments (“ANPRM”) seeking to obtain information and public comment on how to efficiently and effectively implement the civil monetary penalty (“CMP”) authority provided by Section 7102(a) of the Patient Protection and Affordable Care Act (“Affordable Care Act”), Pub. L. 111-148. See 75 Fed. Reg. 57,230 (Sept. 20, 2010).

BIO Comments to USPTO on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System

Nov 19 2010
BIO commends the PTO for exploring creative and market-oriented ways to incentivize the development and distribution of humanitarian technologies, a goal that BIO and its members have long shared and are working hard to achieve.

Food Labeling; Labeling of Food Made From AquAdvantage Salmon

Nov 19 2010
BIO submitted comments to the U.S. Food and Drug Administration (FDA) regarding the application of the food labeling laws and principles to food from the genetically engineered AquAdvantage salmon currently under consideration for approval by the FDA. BIO reiterates its strong support for FDA’s science-based labeling requirements that apply to all foods, which state "no special label is required if a new food is substantially equivalent to its traditional counterpart."

Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials

Nov 8 2010
BIO's comments to the FDA supporting the goals of the Draft Guidance to reduce the potential for suicidal behavior, ideation and attempts during drug treatment.

FDA: Strategic Priorities for Fiscal Year 2011-2015

Nov 1 2010
BIO supports FDA’s initiative to establish a long-term vision for the Agency based upon guiding principles and expresses the biotechnology industry’s willingness to work with the Agency to promote biomedical innovation, modernize regulatory science, further secure the global supply chain, and meet the needs of special populations.

FDA Guidance Document: Transdermal Drug Delivery Systems

Nov 1 2010
BIO appreciates FDA’s efforts to provide industry with additional clarity around the Agency’s current thinking and expectations regarding product manufacturing, yet we believe that this guidance document is unnecessary as the key principles contained within are covered by other means, including regulation and guidance.

Plant Biotechnology: Proposed Labeling of Foods and Food Ingredients obtained through Certain Techniques of Genetic Modification/Genetic Engineering

Oct 29 2010
There is no fundamental difference in foods and food ingredients derived through the use of biotechnology from foods in the marketplace globally.

Patient Therapy: Patient Medication Information

Oct 29 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs."

BIO's comments to the FDA supporting the goals of the Draft Guidance to reduce the potential for suicidal behavior, ideation and attempts during drug treatment.

Oct 29 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs." The comments elaborate on previous comments and further address the questions raised at the September 27-28 public hearing. The comments support the development of effective Patient Medication Information (PMI) that reinforces communication between the patient and healthcare professionals, enables understanding of benefits and risks of a product, and promotes safe and effective use of medication. The comments endorse a single patient-oriented document written by the Sponsor, reviewed and approved by FDA, and based on a template that has been validated through social-science research of patient comprehension. The comments also state that technology should be leveraged to enhance electronic dissemination and distribution of PMI.