Search Results for keywords:"confidential information submission"

The Food and Drug Administration (FDA) has set January 1, 2024, as the uniform compliance date for food labeling regulations that were published between January 1, 2021, and December 31, 2022. This means any new food labeling rules released during this timeframe must be followed by the start of 2024 to reduce the economic impact of labeling changes on the food industry. The FDA states that while these regulations don't immediately introduce new costs, they allow businesses time to adjust their labeling practices. The rule also specifies that special circumstances may justify a different compliance date, which will be detailed as needed.

The Food and Drug Administration (FDA) announced the availability of guidance documents related to the COVID-19 public health emergency. The guidance has been released without prior public comment to expedite the response to the pandemic but remains open for public input. Electronic or paper comments on these documents can be submitted through designated channels. These guidelines reflect the FDA's current practices and do not impose any binding obligations but serve as recommendations for the industry and relevant stakeholders.

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance titled “Considerations for Including Tissue Biopsies in Clinical Trials.” This document offers advice on implementing tissue biopsies in clinical trials, whether conducted on adults or children, especially when evaluating investigational medical products supported by the Department of Health and Human Services (HHS). It emphasizes that while biopsies can pose risks, they can be vital for certain trial evaluations, and often, participation in such biopsies should be optional if they serve exploratory or non-essential purposes. The guidance is open for public comment until March 10, 2025.

The Commodity Futures Trading Commission (CFTC) has released a notice about an Information Collection Request (ICR), submitted for review under the Paperwork Reduction Act of 1995. This collection relates to the clearing exemption for swaps between certain affiliated entities. The CFTC intends to use the collected information to oversee the use of this exemption and evaluate market risks. Public comments on this request can be made until March 3, 2025.