Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation? At the same time, we have to find and implement actions that improve the significant variance in accessing new medicines across Europe.

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Drug Discovery World

FEBRUARY 10, 2023

In Sweden for instance, this year Uppsala University was ranked as 23rd in the world for Pharmacy & Pharmaceutical Sciences reflecting the strong talent base the country has throughout its life sciences sector. Indeed, for the first six months of 2022, medicines accounted for 7.1%

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Agency IQ

AUGUST 4, 2023

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. In March 2022 (i.e., In July 2022, the agency released another two revised draft guidance documents on identifying trading partners (originally drafted in 2017) and interoperable data exchange (originally issued in 2014).

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Agency IQ

JANUARY 26, 2024

In its 2022 annual report to Congress on drug shortages, the FDA notes that one method of mitigating a shortage – once the agency is aware of the shortage at all – is “reviewing requests for extensions of expiration dating.” However, this is not an agency-initiated effort.

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Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. active pharmaceutical ingredient, fill/finish, packaging/labeling). The sales data evaluated was from 2022, which.

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Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. The rule, will also, if finalized, address communication with State boards of pharmacy. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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