14,474 results found

FDA is requiring certain labeling, sterilization validation, and biocompatibility assessments for identified health risks, such as adverse tissue reaction, infection, and reflux or renal damage.

FDA will hold a public meeting on the Draft EIS on February 10, 2015. Comments due March 13, 2015.

In the January 7, 2015, Federal Register, FDA announced the availability of letters containing its initial determinations and feedback on safety and effectiveness data submitted by sunscreen manufacturers.

The fee rates are effective October 1, 2015, and will remain in effect through September 30, 2016.

In the October 6, 2015, Federal Register, FDA announced that it would reopen the comment period for the draft guidance published on June 1, 2015...

In the January 22, 2016, Federal Register, FDA corrected an error made in the proposed rule published November 18, 2015, titled "Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods."

FDA reopened the comment period on its draft guidance for industry on declaring "evaporated cane juice" as an ingredient on food labels.

The proposed rule would establish requirements concerning "gluten-free" labeling for foods that are fermented or hydrolysed...

In the February 6, 2015, Federal Register, FDA reopened the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012...

FDA is reopening the comment period in response to a request for an extension to allow interested persons additional time to submit comments.

In the November 24, 2014, Federal Register, FDA requested public comments on Demographic Subgroup Data for FDA Approved Products on its website.

FDA requested comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine when they are administered in the feed or water of food-producing animals.

In the September 21, 2015, Federal Register, FDA requested nominations of individuals to serve as a voting consumer representative to the Patient Engagement Advisory Committee.

FDA will use the information gathered from public comments in the design and development of pilot project(s) established under the DSCSA.

Organizations interested in helping select the nonvoting representatives should notify FDA.

Industry organizations interested in participating in the selection of the nonvoting representatives should notify the FDA.

In the January 23, 2015, Federal Register, FDA requested nominations for members to serve on the Science Board to the FDA's Office of the Commissioner, Office of the Chief Scientist.

Industry organizations interested in participating in the selection of the nonvoting industry representative(s) should notify FDA.