14,474 results found

In the March 9, 2016, Federal Register, FDA issued a guidance for industry titled "Ensuring Safety of Animal Feed Maintained and Fed On-Farm," which intends to help animal producers...

The FDA announced a guidance document on the"Public Availability of Advisory Committee Members' Financial Interest Information and Waivers".

In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA's latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent...

This guide is intended to help small entities comply with one of FSMA's final rules entitled " Mitigation Strategies to Protect Food Against Intentional Adulteration,"

Final rule prohibits certain nutrient content claims for foods, including conventional foods and dietary supplements that contain omega-3 fatty acids...

The final rule became effective January 26, 2016, but has staggered compliance dates starting January 26, 2017.

As discussed above, in the November 23, 2015, Federal Register, FDA announced the availability of a draft guidance for industry titled "Over-the-Counter Sunscreens: Safety and Effectiveness Data."

In the November 23, 2015, Federal Register, FDA announced the availability of a draft guidance for industry titled "Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process."

FDA has issued a guidance for industry called Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments—Small Entity Compliance Guide.

Earlier this week, FDA issued a letter to industry recommending that bottled water manufacturers, distributors, and importers limit the amount of fluoride they add to bottled water to no more than 0.7 milligrams per liter.

On July 1, 2015, FDA announced it will begin taking enforcement action against companies that manufacture or distribute certain unapproved prescription ear drop products, known as otic products.

FDA proposed that the food additive regulations be amended to provide for the safe use of ethoxyquin in rendered fats and oils used in animal feed.

FDA issued a notice of petition proposing that the food additive regulations be amended to provide for the safe use of L-selenomethionine in animal feed.

Cholbam is a bile acid indicated for the treatment of bile acid synthesis disorders and other peroxisomal disorders.

In the December 8, 2014, Federal Register, FDA published a notice regarding its new system of records containing information about state and local officials...

In the December 18, 2014, Federal Register, FDA proposed a rule amending its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information...

In the April 4, 2016, Federal Register, FDA issued a proposed rule to amend its nonprescription OTC drug regulations.

In the February 27, 2015, Federal Register, FDA amended its postmarket electronic Medical Device Reporting ("eMDR") regulations.