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ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

FDA Law Blog: Biosimilars

FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.

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FDA Denies Vanda’s Citizen Petitions Regarding the Need for Braille Labeling for Tasimelteon Generics

FDA Law Blog: Biosimilars

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Navigating the regulatory landscape for nutraceutical startups in India

Express Pharma

This can include everything from product testing and labelling to marketing and advertising requirements. Challenge 4: Quality control and safety concerns Nutraceutical startups must ensure that their products meet quality and safety standards, as well as comply with labelling and advertising regulations.

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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions. package labeling is optional). It includes questions about the product, that when answered, reveal additional information that should be supplied with a submission.

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different.

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What is Special about September 24, 2023 for the UDI System?

FDA Law Blog: Biosimilars

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Devices can have both a UPC code and a UDI on their label and package. Emphasis added.)