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Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M.

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In the News: October 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The guidance also contains some useful information, despite the limitations described above.

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Will An Upcycled Certification Mark on Packaged Foods Resonate With Consumers?

XTalks

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. The definition ultimately served as a jumping-off point for the UFA to develop its certification marker and membership. Even before the term was formally defined, upcycled foods had been gaining momentum.

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Q&A: The IND Journey Phase I – Navigating Success

Advarra

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? For good clinical practice (GCP), refer to ICH E6 (R2) Section 5 and address all quality elements.

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Submitting a 510(k)? Keep Hoarding Blank CDs

FDA Law Blog

As that program was underway, FDA developed another pilot program for electronic 510(k)s using the electronic submission template and resource (eSTAR). It defines an electronic submission, or eSubmission, as a “submission package produced by an electronic submission template that contains the data of a ‘complete’ submission.”

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Can Natural Food Dyes from Cabbage Replace Synthetic Options?

XTalks

The color cyan blue is not easy to find in nature, making this discovery significant for the industry’s innovation and developments. Scientists used synthetic biology and computational protein design tools to develop an enzymatic process to transform red cabbage anthocyanins into their desired color. 1, FD&C Blue No.

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Statement from Pfizer Chairman and CEO Albert Bourla on Testing Positive for COVID-19

Pfizer

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Loss of therapeutic effect of PAXLOVID and possible development of viral resistance. FDA Emergency Use Authorization Statement. 08.11.2022.

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