Drug

Subscribe to Drug

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On April 20, 2012, the U.S. Food and Drug Administration (FDA) announced the availability of two draft guidance documents addressing the use of nanotechnology, “Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging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…

On September 23, 2010, the Food and Drug Administration (FDA) will hold a public workshop entitled “Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.” According to FDA, the purpose of the workshop is to obtain information on manufacturing, characterization, and biocompatibility evaluation of medical devices containing or using nanomaterials and nanostructures, including diagnostics. FDA…

On July 20, 2010, Representative Janice Schakowsky (D-IL) introduced the Safe Cosmetics Act of 2010 (H.R. 5786), which would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) “to ensure the safe use of cosmetics.” Under the bill, the Secretary of the Food and Drug Administration (FDA) would:

  1. Monitor developments in the scientific understanding of any

…

On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls…