Remove Documentation Remove FDA Remove Pharmaceutical Companies
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STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems

STAT

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

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Global regulators seek permanent working group on AI

pharmaphorum

Sponsors and developers of AIs – including pharmaceutical companies – should set up governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product.

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The criticality of compliance

pharmaphorum

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. In fact, the FDA cited data as the cause of 79% of Drug Warning Letters over the last five years.

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How to use Pay Per Click Advertising to Reach HCPs in Pharma

Pharma Marketing Network

Brand Authority: By appearing at the top of search engine results, pharmaceutical companies increase brand credibility among HCPs. Use a mix of: Branded Keywords: Drug names, pharmaceutical companies, or treatment-specific terms. Competitive Keywords: Terms related to rival brands, helping capture market share.

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How to become a regulatory affairs pharmacist

The Checkup by Singlecare

In order to test, market, and release drugs onto the market, pharmaceutical companies must abide by government regulations and oversight processes. . Regulatory affairs, however, encompasses more than just the pharmaceutical industry. Pharmacists who work in the private sector typically work for a pharmaceutical company.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.