FDA Announces Updates to Standards for Biologics

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In a Federal Register (FRN) notice, published on May 4, 2016, the Food and Drug Administration (FDA) announced that they will be updating outdated requirements and amending certain standards that relate to general biological products.

In 2011, FRN 13563 was published that tasked Agencies to review policies and standards that can be updated to a more productive structure. In response to this task and after reviewing, “FDA is revising the general biological products standards relating to dating periods and removing certain standard preparations and limits of potency.” It has been found that these changes will modernize outdated technology and eliminate redundant requirements, while still protecting public health.

The amendments to the Biological standards and updates will be effective beginning September 16, 2016. Comments on the rule must be received by July 18, 2016.

The Federal Register notice can be accessed at:

https://www.federalregister.gov/articles/2016/05/04/2016-10385/standard-preparations-limits-of-potency-and-dating-period-limitations-for-biological-products

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