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

Agency IQ

MAY 10, 2024

1537, An Act to Amend the Laws Relating to the Prevention of Perfluoroalkyl and Polyfluoroalkyl Substances Pollution , which contains several important notification and prohibition provisions, including exempting different products from state notification requirements for PFAS , including for medical devices, drugs, and biologics.

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Packaging Regulations Production Compliance 40

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

The Pharma Data

JANUARY 6, 2021

End-to-End Single-Site Solution from Drug Substances to Fill-Finish & Packaging. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand.

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Packaging Small Molecule Production FDA Approval 52

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

Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? 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. no available treatment.

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Marketing Biosimilars Regulations Drugs 40

Agency IQ

APRIL 8, 2024

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. Investigational New Drug, or IND, safety reports) to the FDA in E2B(R3) format.

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FDA Production Regulations Vaccine 40