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In the June 26, 2014 Federal Register, FDA announced the availability of Gluten-Free Labeling of Foods—Small Entity Compliance Guide,

In the October 6, 2015, Federal Register, FDA published a list of premarket approval applications ("PMAs") that have been approved.

Last week, Commissioner Hamburg announced the release of FDA's new strategic planning document setting out the Agency's goals for the next four years.

In the September 25, 2014, Federal Register, FDA has issued a report titled Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS).

On March 28, FDA released a draft guidance Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).

FDA launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets.

The rule is effective August 18, 2016

FDA issued amendments to specific provisions of the proposed rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

In the November 19, 2014, Federal Register, FDA opened a public comment on proposed criteria for "first generic" ANDA submissions. Comments due December 19, 2014.

In the March 9, 2015, Federal Register, FDA announced a public docket to receive information, recommendations, and comments on matters related to the agency's regulation of compounding of human drug products...

On August 1, 2014, FDA released draft guidance proposing to exempt from premarket 510(k) review many low-risk medical devices.

In the September 22, 2015, Federal Register, FDA proposed to amend certain regulations pertaining to registration and process filings related to acidified foods and thermally processed low-acid foods packaged in hermetically sealed containers (also known as "low-acid canned foods" or "LACF").

In the April 13, 2015, Federal Register, FDA announced a proposed rule to clarify language in federal performance standards on ionizing radiation.

FDA is required to report on PMA approvals and denials every quarter.

In the October 6, 2015, Federal Register, FDA published a list of premarket approval applications ("PMAs") that have been approved.

Specifically, this publication adds a list of recognized standards relevant to safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.

These modifications will be incorporated in the list of FDA Recognized Consensus Standards in the Agency's searchable database.

A mineral additive manufacturer has filed a petition proposing the food additive regulations be amended to provide for the safe use of zinc L-selenomethionine.