The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the
The National Oceanic and Atmospheric Administration and the U.S. Department of Agriculture Agricultural Research Service have released their strategic plan for national aquaculture research and development (Strategic Plan). The Strategic Plan has potentially significant implications for aquaculture companies, feed suppliers, and other stakeholders interested in seafood and related nutrition policy matters.
The Strategic Plan was…
The Presidential Commission for the Study of Bioethical Issues has released its report “Moral Science: Protecting Participants in Human Subjects Research.” The report was requested by President Obama to determine if current regulations adequately protect human subjects in federally funded research. The Commission determined that current regulations “generally appear” to protect participants from harm or unethical treatment, “as far as is feasible given limited resources,” but that it cannot say if current regulations are optimal for protecting against avoidable harm and unethical treatment because some agencies have limited ability to identify basic information about all human subject research.
On December 13, 2011, FDA announced the availability of a draft report entitled “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” for public comment. The literature review was conducted pursuant to section 3507(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) which required the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in standardized format (e.g., similar to the “Drug Facts” on over-the-counter-products) to the promotional labeling or print advertising of such drugs would “improve health care decision-making by clinicians and patients and consumers.”
Continue Reading FDA makes “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” available for comment