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Advanced Solutions for Sustained Delivery of Ocular Therapies

PharmaTech

While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). PLoS ONE 2011 6, e24513. DOI:10.1089/jop.2022.0144

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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. Additional concerns for the caregiver include a strain on physical and mental health. February 2019.

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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. The worldwide trend of using botanical drugs and strategies for developing global drugs.

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FDA Flexes its New FDORA Muscles in Withdrawing an Accelerated Approval

FDA Law Blog: Biosimilars

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Notably, this decision marks the first use of the new expedited procedures for withdrawal of an accelerated approval that were enacted in the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmaTech

Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B.