Recent FDA compounding guidances raise hackles.

One of the most effective ways in which regulatory agencies communicate with sponsors and guide drug development is through the issuance of guidances or guidelines. These can be issued domestically in a given region such as the United States by the Food and Drug Administration (FDA) or internationally through the International Conference on Harmonization. Currently, there are over 400 final or ...

he main objective of the advertising discourse is to encourage its viewer or reader to buy goods. this dialogue contains several inductive functions, including inductive functions of action and tension. the function of the induced action is an action-induced origin, whereas the function of the inductive tension is induced by the action originated. thus, tension-induced functions can be claimed ...

Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to- consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances ...

The study sought to explore approaches for co-creation of conservation agriculture (CA) knowledge amongst farmers, nongovernmental organizations (NGOs), government and specialist researchers. The aim of the study was to explore farmer initiated food security strategies among small holder resource poor farmers, through enhancement of farmers’ own productive capacity. The study was born out of th...

The Food and Drug Administration issued draft guidances in January that tackled health care economic information and product labeling. Do these publications indicate a potential shift in on- and off-label policies for drugs and devices?