European Pharmaceutical Review

JULY 4, 2024

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

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

OCTOBER 10, 2022

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

FDA Food and Drug Administration Side effects Food 105

European Pharmaceutical Review

JULY 13, 2023

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

Medical Food and Drug Administration Pharmacology Medicine 98

European Pharmaceutical Review

SEPTEMBER 22, 2023

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.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

European Pharmaceutical Review

AUGUST 10, 2022

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.

Food and Drug Administration 96

Food and Drug Administration Medicine FDA Government 96

European Pharmaceutical Review

APRIL 8, 2025

One element that project managers often forget or underestimate is the environmental, health and safety (EHS) tasks” Operating PAT from hardware to software, in a manufacturing suite, would not be successful without training and competency development to track training status in a learning management system for individuals.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52