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Firm News 1 result

Firm News | 6 min read | 01.02.24

Crowell & Moring Elects Seven New Partners, Promotes Four to Senior Counsel, and 26 to Counsel

Crowell & Moring elected seven lawyers to the firm’s partnership, effective January 1, 2024. The firm also promoted four lawyers to the position of senior counsel and 26 associates to the position of counsel.

Client Alerts 7 results

Client Alert | 1 min read | 01.12.24

FDA Announces Availability of Decision Tool and SPL Xforms For MoCRA Facility Registration and Product Listings

On January 8, 2024, the U.S. Food and Drug Administration (FDA) announced that SPL Xforms, a Structured Product Labeling authoring tool, is now available as an additional option for completing facility registration and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As a result, companies may submit their facility registration(s) and product listing(s) in one of four ways:

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Client Alert | 4 min read | 12.21.23

FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA

On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.

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Client Alert | 2 min read | 12.18.23

FDA Provides Updated Instructions for Reporting Serious Adverse Events Under MoCRA

On December 14, 2023, the FDA issued an update with further instructions on serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.

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