14,474 results found

In the August 20, 2015, Federal Register, FDA announced the establishment of a public docket to receive comments from interested parties on enhancing the utility and usability of the Inactive Ingredient Database.

The FDCA requires FDA to consult with a range of stakeholders in developing recommendations for the next GDUFA program.

In the October 6, 2015, Federal Register, FDA announced it is reopening the comment period for the "Established Conditions: Reportable Chemistry, Manufacturing, and Controls ("CMC") Changes...

In the June 30, 2016, Federal Register, the FDA announced the extension of the comment period for a draft guidance titled "Inorganic Arsenic in Rice Cereals for Infants: Action Level".

This provision of the MMA governs the approval of 505(b)(2) applications and ANDAs.

In the March 9, 2015, Federal Register, FDA announced it is extending the comment period for the proposed rule, announced December 18, 2014, to amend labeling regulations for human prescription drugs...

In the December 24, 2014, Federal Register, FDA announced that it has extended the comment period regarding the Agency's implementation of the Rare Pediatric Disease Priority Review Vouchers Program.

FDA is seeking to expand the scope of the Redbook to emphasize principles of safety and risk assessment shared across different regulatory contexts for foods and cosmetics...

The consumer studies pertained to proposed changes to the Nutrition Facts label formats.

In the May 23 Federal Register, FDA announced that it will extend the comment period on the sanitary transportation proposed rule by 60 days.

In the December 28, 2015, Federal Register, FDA announced the extension of the comment period for a docket to receive comments on use of the term "natural" on labeling of human food products...

In the July 10, 2015, Federal Register, FDA announced a one-year extension of the compliance date for the final rule on Menu Labeling...

In the July 20, 2015, Federal Register, FDA announced it was extending the nomination period for bulk drug substances that may be used by facilities registered as outsourcing facilities to compound animal drugs from bulk substances.

FDA announced an extension of its call for nominations and for industry organizations to participate in the selection of nonvoting industry representatives to serve on the Food Advisory Committee for CFSAN.

FDA announced the filing of a petition, submitted by McCormick & Company, Inc., that proposes that the color additive regulations be amended to provide for the safe use of spirulina extract to color shell eggs.

In the December 30, 2014, Federal Register, FDA announced that the Agency has filed with the Library of Congress the annual reports of FDA advisory committees that held closed meetings during fiscal year 2014.

FDA finalized policies for the public disclosure of financial ties of advisory board members whose votes prove critical to the approval of new drugs.

The FDA released two Guidances and finalized the rule implementing its expanded authority to access records of food manufacturers.