Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

Regulations 40

Regulations International Pharmaceuticals Production 40

Agency IQ

JULY 12, 2024

In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. The Commission’s communication was accompanied by a Q&A document defining key terms and ideas, including how the effort was related to ongoing efforts to overhaul the pharmaceuticals legislation.

Regulations 40

Regulations Packaging Production FDA 40

Agency IQ

JUNE 21, 2024

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. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation.

Regulations 40

Regulations Marketing Production Vaccine 40

Drug & Device Law

MAY 30, 2022

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.

Testimonials 59

Testimonials Doctors Production Laboratories 59