The Food and Drug Administration (FDA) is scheduled to publish a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.”  According to the pre-publication version of the notice, FDA developed the guidance to provide industry with its current thinking for the development of

The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled “Guidance for Industry:  Use of Nanomaterials in Food for Animals.”  The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the

On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients

A coalition of nonprofit consumer safety and environmental groups sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of California on December 21, 2011.  The coalition is led by the International Center for Technology Assessment (ICTA), and includes Friends of the Earth, Food and Water Watch, the Center

On October 6, 2011, Senator Mark L. Pryor (D-AR) introduced the Nanotechnology Regulatory Science Act of 2011 (S. 1662), which is intended to address potential health and safety risks from products that contain nanotechnology materials. The bill would establish a program within the U.S. Food and Drug Administration (FDA) to assess the health and safety implications

The U.S. Food and Drug Administration (FDA) released on August 17, 2011, a document entitled Advancing Regulatory Science at FDA: A Strategic Plan. FDA states that its core responsibility is to protect consumers by applying the best possible science to its regulatory activities.  FDA notes that rapid advances in innovative science have provided new technologies to

The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several