14,474 results found

Revised Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing, May 13, 2015, Federal Register.

As discussed above, in the May 2, 2016, Federal Register, FDA announced the availability of Compliance Policy Guide ("CPG") Sec. 690.150...

The agency is revising the guidance to correct an inaccurate statement.

This revised draft provides guidance for FDA staff on the level of E. coli in crabmeat at which the agency may consider the crabmeat adulterated with filth under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

FDA issued draft guidance for industry on the preparation of petitions and notifications for exemptions from the labeling requirements for major food allergens.

The guidance, when finalized, will describe FDA's policy on how to determine the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.

On August 4, 2014, FDA issued a draft guidance titled Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.

Last month, FDA released a draft guidance document detailing the ways in which data from clinical studies outside the United States can be used in support of medical device premarket submissions.

The draft guidance also includes limited discussion of certain other applicable requirements of the Produce Safety Rule.

For this guidance, FDA considered the comments requested on the draft guidance of June 2014.

FDA announced the availability of final guidance titled Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration.

In the April 15, 2016, Federal Register, FDA issued a final rule to amend the food additive regulations at 21 C.F.R. § 172.345 to provide for the safe use of folic acid in corn masa flour at levels not to exceed 0.7 milligrams per pound.

The final rule implements provisions of the ACA and is intended to make nutrition information available to consumers in a direct and accessible manner.

Vending machine operators not otherwise covered by the law may elect to be subject to the requirements by registering with FDA.

This amendment was made in response to a food additive petition filed by Kemin Industries, Inc. on March 10, 2014.

In the May 27, 2016, Federal Register, as part of FSMA implementation, FDA issued a final rule requiring registered food facilities to address hazards that may be introduced with the intention to cause wide-scale public health harm.

In the June 15, 2016, Federal Register, FDA issued a final rule revising the Agency's medical device and certain biological product labeling regulations.