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Article EMA Thank You European Commission reveals action plan to address medicines shortages

Agency IQ

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Changes that could be implemented rapidly include using different sources of raw materials and/or finished product, packaging, or changes to batch sizes, manufacturing sites, and equipment. healthcare systems for years.

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Sebastian MacLean’s Naturally Massive

The Pharma Data

In fact, our “Average Joe” made such a dramatic transformation that, after filming of Facing Goliath was complete, he went on to be awarded the world wide Body For Life inpirational champion award of 2001. Your program takes nutrition, supplementation, and exercise and coordinates them as total package.

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Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

While the SRP could be used to submit information on drugs and biological products, the only exception was for vaccines. This week, the FDA made significant progress towards the full implementation of E2B(R3) requirements. Investigational New Drug, or IND, safety reports) to the FDA in E2B(R3) format.

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Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Agency IQ

It applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC, but does not apply to the transfer of the marketing authorization from one holder to another. Chapter 4 of Directive 2001/83/EC allows Member States to recognize assessments from another E.U.

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

1981) (applying Virginia law), both of which involved vaccines. In Stanback the prescriber had a similar practice of not warning of a “slight risk,” which led to the same result: [The prescriber] averred that he had not found it necessary and did not make it his practice to advise patients about the risks associated with flu vaccinations.

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A Texas Mess

Drug & Device Law

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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