Banks that provide cord blood products for use in an unrelated individual (public use) must follow these and additional FDA requirements.

Sea Grant programs around the nation provided standardized HACCP training that help businesses comply with FDA requirements and stay in operation.

While this remains the primary tool of postmarket safety surveillance, FDA requirements for postmarketing risk management are increasing.

The FDA requirement for dietary modifications for the 9 mg and 12 mg doses are based on theoretical concerns, as no adverse events due to diet have ever been reported.

The trial court rejected this argument, as did the Supreme Court of Vermont, holding that the FDA requirements merely provide a floor, not a ceiling, for state regulation.

Herbalife responded stating its products met federal FDA requirements and released independent laboratory tests it said proved the products did not exceed Proposition 65 limits.

Because of the risk of severe bleeding, associated with the use of Xigris, the following guidelines have been additionally proposed, but are not FDA requirements:

On June 9, the company met with FDA officials to determine FDA requirements.

The FDA requirements are rigorous and costly.

As a result, the FDA, sponsors, core laboratories, and device manufactures worked together within HL7 to create a standard to meet the FDA requirements.