The Food and Drug Administration on Dec. 9 issued new guidance on the labeling of prescription drug and biological products. In “Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format” (here), FDA provides guidance on how to decide what topics to include in the patient counseling information section, as well as how to present information and organize the section, it said.
On Dec. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for Dec. 3 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On Dec. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Nov. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration posted new guidance on the labeling of products that do not contain natural latex (here). FDA says some companies are labeling their drugs, devices and biologics as “latex free” or “does not contain latex.” However, there is currently no test that can back up a claim that a product is completely latex-free, said the agency. Instead, companies should label their products as “not made with natural rubber latex.” If a company wants to say a specific product or part isn’t made with natural latex, it should say “the [product] is not made with natural rubber latex,” said FDA. Although FDA said the guidance is not binding, the agency told manufacturers that currently include statements like “latex-free” or “does not contain latex” to update their labeling to show FDA’s recommended labeling statement, or consider removing any such statements altogether.
On Nov. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: