The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...

The US Food and Drug Administration (FDA) released new guidance on 27 March for benefit-risk determinations in premarket approvals (PMAs) and de novo classifications for medical devices. The guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , "is intended to provide greater clarity on FDA's decision making process," FDA wrote. According to the guidance document, "this guidance sets o...

Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global scandal, reports Reuters . "Health regulator Anvisa will require implants to be certified through the national quality control institute Inmetro to ensure products meet new criteria including physical strength, tear resistance and absence of toxic substances," wrote Reute...

Worsening shortages of some critical drugs are causing some groups to criticize US Food and Drug Administration (FDA) and Center for Medicare and Medicaid Services (CMS) regulations that the groups claim are causing providers to dispose of potentially useful medications. MSNBC reports that "organizations such as the Institute for Safe Medication Practices and the American Society of Health-System Pharmacists are raising questions about federal rules they belie...

The National Institutes of Health (NIH) released a new website on 6 February called NIH Clinical Research Trials and You that aims to educate the public about clinical trials and how to participate in them. "Clinical trials are essential for identifying and understanding ways to prevent, diagnose, and treat disease," said NIH in a press release . "Research has shown that among the greatest challenges to recruitment of volunteers is the lack of general knowledge abou...

The scandal surrounding French adjuvant therapy in hypertriglyceridemia and overweight diabetics drug Médiator, and the many deaths apparently linked to the product directly led to enactment of  The French Act N°2011-2012   of 29 December 2011 by the National Assembly. The law, sponsored by France's Ministry of Labor, Employment and Health to restore public confidence and enhance the safety of medicinal and health products, affects all stakeholders ...

The US Department of Health and Human Services (DHHS) released new draft regulations on Friday, 27 January that would implement portions of the Patient Protection and Affordable Care Act (PPACA) by revising reimbursement methodologies for outpatient drugs covered by Medicaid. Medicaid currently allows states to provide coverage of outpatient drugs to patients. Under the PPACA , DHHS is required to adjust the requirements for rebate agreements, drug pricing submission ...

A recent study published by the Harvard School of Public Health indicates that US consumers are largely in favor of government and private insurance plans covering treatment regimens determined to be experimental. 62% of study participants indicated that they "oppose decisions by the government or health insurance plans" to deny enrollees reimbursement for experimental or cost-ineffective treatments. Many government programs and private insurers will not provide reimbur...