2001, Documentation and Pharmaceutical Companies

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2001

Documentation

Pharmaceutical Companies

Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceutical companies. They detail the medication’s intended use, proper administration, potential side effects and precautions.

Packaging

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA

FDA Documentation Compounding Pharmaceutical Companies

Pharmacy Technician Pulse

Bridging the healthcare digital divide: a gradual approach to adopting ePI

Botanical drugs – what is the best way forward for regulatory and market approval?

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