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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

It noted that US law requires complete manufacturing addresses to be printed on generic drug packaging and listed in the FDAs Orange Book database. Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin.

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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What happened to all the antibiotics?

pharmaphorum

These include allowing the exceptional supply of certain medicines that may not be authorised in a particular Member State or granting full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of some medicines.”

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Complex generics: Are global regulators addressing the needs?

Quality Matters

Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. Quality standards in particular help ensure medicines are safe, work as intended, and are available when needed, no matter the company producing them or where they are made.

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