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

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103
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First FDA pregnancy-approved Pertussis vaccine to protect newborns

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age.

FDA 105
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The future of medical cannabis development in Europe

European Pharmaceutical Review

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful.

Medical 98
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Monkeypox update – August 2022

European Pharmaceutical Review

the co-ordination of independent monitoring studies on the use, effectiveness and safety of medicinal products intended to be used against monkeypox. Second meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country outbreak of monkeypox [Internet]. About the author. References.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.