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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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Nitrosamine drug substance-related impurities (NDSRIs)

European Pharmaceutical Review

FDA briefing documents that address these reformulation strategies should include a description of the formulation design strategy that is employed to minimise the formation of NDSRIs in the drug product, including supporting manufacturing information and, at a minimum, three months of accelerated stability data demonstrating control of NDSRI.

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NHC Comments on the Federal Evidence Agenda on Disability Equity

Putting Patients First Blog

When combined with the challenges of living with a disability, these individuals may encounter compounded discrimination and systemic biases. https ://www.federalregister.gov/documents/2024/03/29/2024-06469/revisions-to-ombs-statistical-policy- directive-no-15-standards-for-maintaining-collecting-and 2 National Minority Quality Forum.

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

European Pharmaceutical Review

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.

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How Thyroid Disease Affects Men

The Thyroid Pharmacist

A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! In fact, in 2006, the Centers for Disease Control reported that the average American has 116 out of the 148 commonly tested synthetic compounds in their body. Published 2004 Aug 18.