14,474 results found

In the November 4, 2014, Federal Register, FDA announced a public docket for comments on Patient Participation in Medical Product Discussions under FDASIA.

In the November 25, 2016, Federal Register, FDA issued a final rule establishing January 1, 2020, as the uniform compliance date for food labeling regulations...

FDA announced it would extend the comment period for the Draft Guidance for Industry and Food and Drug Administration Staff: Informed Consent Information Sheet.

In the May 27 Federal Register, FDA announced that it will extend the comment period for its proposed revisions to the Nutrition and Supplement Facts labels.

The U.S. House of Representatives Committee on Appropriations voted 31–18 to increase FDA's 2015 fiscal year budget by nearly $2.6 billion.

In the July 8, 2015, Federal Register, FDA announced it is amending its regulations to implement certain drug shortages provisions of the FDCA.

The final guide provides guidance for FDA staff on the agency's labeling requirements for processed and blended seafood products made primarily with fish protein.

In the April 22, 2015, Federal Register, FDA announced corrections to the final rule entitled "Administrative Detention of Drugs Intended for Human or Animal Use."

FDA issued two corrections regarding the withdrawal of certain approved abbreviated ANDAs for prescription drugs containing more than 325 mg of acetaminophen.

FDA issued this EUA pursuant to the Federal Food, Drug, and Cosmetic Act ("FDCA") at the request of the applicant.

FDA issued an emergency use authorization ("EUA") for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus.

In the September 1, 2015, Federal Register, FDA announced the issuance of an EUA for an in vitro diagnostic device for detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

In the April 15, 2016, Federal Register, FDA announced the availability of guidance for industry titled...

FDA reclassified nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III into class II.

In the August 12, 2014, Federal Register, FDA issued a final rule amending its food additive regulations to permit the use of vitamin D3 as a nutrient supplement in meal replacement beverages other than those intended for special dietary use in reducing or maintaining body weight and for use in foods that are sole sources of nutrition for enteral feedings.

As noted above, in the December 14, 2016, Federal Register, FDA issued a final rule amending its regulations on accreditation of third-party certification bodies to conduct food safety audits...

In the May 29 Federal Register, FDA issued a final rule creating the implementing regulation for the administrative detention of drugs.

FDA issued a final rule amending the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer.