FDA Roundup: August 20, 2024
Regulatory2024-08-20
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- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA approved Lazcluze (lazertinib) in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Full prescribing information for Lazcluze and Rybrevant will be posted on Drugs@FDA.
- Save the Date: On Dec. 17 and 18, 2024, there will be a joint NIH-FDA Nutrition Regulatory Science Workshop. The goal of this joint NIH-FDA workshop is to highlight how nutrition science can generate evidence and data to inform food-related policy and regulatory decision making and to foster additional collaboration between NIH and FDA in supporting research that addresses priority nutrition research gaps. Examples of topics that will be discussed at the workshop include ultra-processed foods, impact analysis and implementation science related to regulatory actions, and emerging technological innovations related to nutrition regulatory science.
Related Information
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Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Inquiries
- Consumer:
- 888-INFO-FDA
Source: U.S. Food and Drug Administration (FDA.gov)
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