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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Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

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FDA Science Regulations Biosimilars 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

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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Production Regulations Compliance Packaging 40

Agency IQ

APRIL 8, 2024

Once E2D(R1) has been finalized following comments received during public consultation, the note stated that “the final changes will be published via the E2B(R3) Implementation Guide package and ICH E2B(R3) Questions and Answers document.” This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements.

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

MARCH 29, 2024

The proposal builds upon EPA’s final standards for federal greenhouse gas emissions standards for passenger cars and light trucks for model years 2023 through 2026. 7521(a), starting with model year 2027.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JULY 12, 2024

To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com ).

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Regulations FDA Science Production 40

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. The most common drug Californians may be looking for this winter is Paxlovid.

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Licensing Licensing Pharmacy Packaging 59

Perficient: Drug Development

APRIL 15, 2025

Some of the challenge themes included: Internal Idea & Innovation Hub, Skills & Project Matchmaker , Ready to Integrate AI Package etc. Were already looking forward to Perfathon 2026. The open-ended format allowed teams to think outside the box, pick what resonated with them, and own the solution-building process.

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International Packaging Production 52

New Drug Approvals

APRIL 27, 2025

This article incorporates text from this source, which is in the public domain. ^ “Drug Approval Package: Flyrcado Injection” U.S. Flurpiridaz F 18 WeightAverage: 367.84 3] Flurpiridaz ( 18 F) It is given by intravenous injection. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3]

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FDA Clinical Trials FDA Approval Disease 57