Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Under the proposal, these elements would be addressed within the revised pharmaceutical regulation, thereby addressing drug shortages at a consistent, E.U.-wide healthcare systems for years. wide level.

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The Pharma Data

MAY 15, 2021

A system so powerful that, when it was first revealed, drug testing was required to prove it was real! Our goal was to cover my effort to get big enough to do well nationally, drugs free, and to see if we could turn our average Joe into a bodybuilder within the first year of our meeting. Description: . Too Good To Be True?…

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Agency IQ

JULY 12, 2024

In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. The non-paper also suggested three potential actions to address drug shortages. Read AgencyIQ’s analysis of the non-paper.]

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Regulations Packaging Production FDA 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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Drug & Device Law

MAY 30, 2022

That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . their patients. 2d at 645.

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Drug & Device Law

JANUARY 4, 2024

The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.

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Vaccine FDA FDA Approval Pharmacy 59