In the first half of 2013, the UN’s Food and Agriculture Organization (FAO) surveyed its member nations about genetically modified (GM) crops in international trade. Of the 75 respondents, 77% had food, feed or environmental regulations for GMOs, while 15% did not, but planned to. In imported food or feed, low level presence (LLP) of […]

As required by 2012’s Food and Drug Administration Safety and Innovation Act, the FDA has submitted to Congress a report on premarket notification of changes to 510(k) devices. The agency will largely maintain the present guidance and policy framework and will publish a draft of its revisions for review. The agency will clarify terms in […]

Venture capital investment in the Life Sciences, which includes the Biotechnology and Medical Device industries, decreased in 2013. Biotechnology showed growth, however, with funding increasing 8% to $4,500 million. Numbers of deals, in contrast, decreased by 2% to 470. In the fourth quarter of 2013, Biotechnology investments grew 43% in value to $1,300 million and […]

The FDA will create the Office of Pharmaceutical Quality to better control quality of branded, generic and over-the-counter drugs in the US. The agency and the pharmaceutical industry are determining which of the data currently acquired from inspections can be collected on an ongoing basis to identify drug plants departing from established standards and needing […]

The FDA is proposing nutrition label updates on foods due to changes in scientific knowledge and dietary habits. Besides listing trans fats as of 2006, labels have largely not changed since their 1994 introduction. Proposed changes will be open to public comment and include updating daily values, nutrients listed and serving sizes. Listing amounts of […]

In 2013, the FDA’s Center for Drug Evaluation and Research approved 25 small molecular drugs and 2 biologic drugs, compared to 33 and 6, respectively, in 2012. Nine orphan new medical entities (NMEs) were approved, as were 8 cancer drugs, of which 6 were orphan NMEs. In addition, companion diagnostics information was provided for 3 […]

In 2005, the NIH initiated the $376 million Cancer Genome Atlas (TCGA) that has successfully identified new cancer genes from 500 samples from more than 20 cancer types. As the project nears its close, investigators are faced with deciding in which direction to proceed. A study by scientists at the Broad Institute of MIT and […]

The passage this month of the Agricultural Act of 2014, or Farm Bill, provides $512 million for scientific research over five years. Funding each year will be 3.8% less than the previous Farm Bill. However, the legislation provides mandatory funding, which will not require approval by Congress each year. The Bill increases funding for organic […]

A study of success rates of clinical drug development analyzed phase transitions in BioMedTracker from 2003 through 2011, including primary and secondary indications. The data set comprised 4,451 drugs from 835 firms. The “likelihood of approval” (LOA) (the probability of a drug reaching FDA approval from its current phase) was 10.4% for phase 1 to […]