Drug Discovery World

MARCH 19, 2024

The company plans to submit an Investigational New Drug (IND) application to the FDA for AT-108 by 2026, expand and reinforce its research and development team, and fuel new reprogramming modalities and delivery platforms to strengthen the pipeline. This financing also follows a strong pre-clinical package providing PoC for AT-108.

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Immune Response Packaging Therapies FDA 130

The Premier Consulting Blog

APRIL 27, 2023

Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 How can you prepare? How can you prepare? ICH electronic Common Technical Document – eCTD v4.0 FDA eCTD v4.0

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Packaging FDA International Pharmaceuticals 52

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 59

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%.

Regulations 40

Regulations Packaging Compliance Production 40

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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Packaging Regulations Production Compliance 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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Government Vaccine Production Science 52