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FDA issues first recommendations on AI for drug development

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines.

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A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. Where to start?

FDA 207
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FDA grants priority review to omalizumab for food allergies

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental Biologics License Application for Xolair ® (omalizumab) for treatment of children and adults with food allergies.

Food 98
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How did pharma develop a vaccine so quickly?

World of DTC Marketing

All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet.

Pharma 307
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Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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Drug safety driving pyrogen testing market expansion

European Pharmaceutical Review

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.

Safety 94
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US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. It also boosts the drug’s safety, tolerability and efficacy.