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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

It is too early to say because we have not seen the whole package of measures yet. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2004. One of the key priorities of the EU’s strategy is to encourage innovation to solve unmet medical needs. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006.

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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

All packaged foods served or sold on transportation carriers (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and.

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Care … Amazon’s Revolutionary Move into Healthcare

Fuld

In just three years, Amazon has put together a package of leading-edge services that have the potential to revolutionize the US healthcare market. Five months later in June, it announced the $753 million acquisition of PillPack and its move into the drug supply chain with mail order pouch packaging services. .

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

Launch of the EU pharmaceutical package The European Commission plans to commence initiatives relating to the European Pharmaceutical Strategy (strategy) with the publication of the revised EU pharmaceutical package scheduled during the first quarter of 2023.

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CMC Requirements for New Drug Registration in Latin America

ISPE

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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Pharmacy practice in emergency care: patient safeguarding

Hospital Pharmacy Europe

ED pharmacy services were surveyed for the first time in 2004. In the UK, safeguarding training for healthcare professionals comprises six levels, which increase in complexity, with separate learning packages for those who care for children or adults. So, UK ED pharmacy practice was born.

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Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” What is extraordinary about this scandal is that the FDA inspected one of the Ranbaxy facilities in 2004. This was around the time the whistleblower was discovering serious problems.

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