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FDA is required, under the Federal Food, Drug & Cosmetic Act ("FDCA") to consult with a range of stakeholders in developing recommendations for the next PDUFA program.

FDA recently released updated draft guidance on how to explain risks to consumers in advertisements and labeling for prescription drugs, particularly the "consumer brief summary."

FDA indicated the revisions should help reduce the number of submissions that are considered "administratively incomplete upon receipt."

FDA is revising the proposed requirements concerning compliance status review of food and foreign suppliers, hazard analysis, and supplier verification activities.

FDA is proposing to require the additions of a Daily Reference Value of 10 percent of total energy intake from added sugars and the declaration of the Daily Value percentage of added sugars to the Nutrition Facts and Supplement Facts.

Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders...

As discussed above, in the November 10, 2015, Federal Register, FDA requested the public to provide information and comments on the use of the term "natural" in the labeling of human food updates.

FDA announced a public hearing to solicit public comment on certain topics relating to implementation of the Generic Drug User Fee Amendments of 2012.

FDA is seeking public input on disease areas that can be addressed through regulatory science research.

FDA encourages interested groups and individuals to submit information on specific medical and biological areas where novel biomarkers can be identified that would meaningfully advance drug development.

FDA also called for nominations for consumer representatives to serve on advisory committees or panels with vacancies.

In the December 8, 2014, Federal Register, FDA issued a notice asking for nominations of nonvoting industry representatives to serve on the Food Advisory Committee for the Center for Food Safety and Applied Nutrition.

FDA published a notice requesting nominations for voting members to serve on the Food Advisory Committee, Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition.

With this partial stay, FDA intends to encourage scientific research into the relationship between diet and health.

FDA announced that its strategy to voluntarily reduce animal antibiotic use has the full participation of the 26 companies with operations affected by the policy.

Earlier this month, FDA announced it was requiring heightened warnings about heart attack and stroke risks on the labels of all non-aspirin, nonsteroidal anti-inflammatory drugs ("NSAIDs"), in prescription and over-the-counter form.

In the May 18, 2015, Federal Register, FDA published its support for the use of Logical Observation Identifiers Names and Codes ("LOINC") in regulatory submissions to the Center for Drug Evaluation and Research...

The conference is intended to provide information about FDA food, drug, and device regulation to the regulated industry.