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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FDA Regulations Packaging Compliance 57

Agency IQ

MARCH 15, 2024

Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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Regulations Packaging Compliance Production 40

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. Packaging line?. TOKYO , Jan. 8 x 20,000L bioreactors for mammalian cells.

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Packaging Small Molecule Production FDA Approval 52

The Pharma Data

JULY 6, 2021

At its Investor Update, GSK announced a package of new financial outlooks and ambitions. Adjusted operating margins are expected to improve from the current mid-20s level to over 30% by 2026. Cash generated from operations is expected to exceed £10 billion by 2026.

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Agency IQ

MAY 10, 2024

As of January 1, 2026, the law will implement a variety of new prohibitions on intentionally added PFAS in products, including in cookware, cosmetics, cleaning products, and most textiles. Recently enacted legislation Maine: On April 16, 2024, Maine Governor JANET MILLS approved L.D.

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Agency IQ

JUNE 28, 2024

Under the law, beginning in January 2026, manufacturers who sell products in Minnesota with intentionally added PFAS must submit a significant amount of information regarding the product.

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Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. The final package, though, may well continue its focus on patient access and affordability.

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