FDA Law Blog: Biosimilars

JULY 10, 2023

In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). When referencing documents within the AI response, cite location within the 510(k) supplement (e.g., Attachment number) and document name or description as appropriate.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Labelling Packaging Documentation 59

Big Molecule Watch

JANUARY 5, 2024

The proposed schedule also provides dates for document discovery and depositions. District Court for the Northern District of West Virginia, alleging infringement of 51 patents under the BPCIA based on Samsung’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA (aflibercept). Patent Nos. Patent Nos. Design Patent Nos.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

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. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Labelling Packaging Documentation 45

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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The Nontraditional Pharmacist

JULY 1, 2025

The last time we spoke, biosimilars were this new thing and everyone was trying to figure out what was going to happen regulatory-wise and a lot of other changes since then. And then how do you develop documents to basically get approval from the FDA to study your drug in humans? I think my daughter was just barely one.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Still, the document provides some guidance (naturally) as to materials required to submit a successful meeting request. And the Guidance may be used as leverage to secure action from FDA on a meeting request. The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

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Packaging Documentation Labelling 45

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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Packaging Documentation Labelling Communication 59

Express Pharma

JUNE 23, 2025

Most projects fail not in the lab, but in study design, regulatory interpretation, and documentation. This article explores why E&L studies go wrong and how to build a submission-ready package from protocol to final report. The reason? They are a risk-based, regulatory-driven evaluation of product safety.

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Packaging Dosage Documentation Biosimilars 63

PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. So why is ICH Q6B so important, and what does it outline?

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Dosage Drug Development Documentation Biosimilars 52

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g., CMS’ final regulation expansively defines a “misclassification” to include not only misclassifying the drug category (e.g., Remarkably, manufacturers may not dispute a CMS notification.

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Vaccines Inpatient Packaging Documentation 59

FDA Law Blog: Biosimilars

JANUARY 20, 2025

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods. The description or name of the food (i.e.,

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Labelling Documentation Packaging 52

RX Note

FEBRUARY 23, 2023

Figures - Elemental iron and calcium content?

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58