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Teva faces EU antitrust probe over MS drug Copaxone

pharmaphorum

billion in annual sales it generated during its peak year in 2013. The Commission will also examine whether Teva may have launched a communication campaign to create a “false perception” about the health risks of prescribing generic competitors, aimed at healthcare professionals and hospitals.

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ISPE’s Regulatory Commenting Process

ISPE

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Offer helpful solutions.

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Taking stock of NHS medicines optimisation

pharmaphorum

Since their inception in 2013, Clinical Commissioning Groups (CCGs) have led medicines optimisation efforts at local level. The Royal Devon and Exeter NHS Trust has used electronic medical records to document and share medicines decisions with GP practices and community pharmacies. A changing healthcare landscape.

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The imperative of fridge-free vaccines

European Pharmaceutical Review

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. 2011;29:7122–7124. Sharma D, Khamar S, Cullen A, et al.

Vaccines 111
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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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How to take care of your BIPOC patients

The Checkup by Singlecare

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. It’s worth considering how you can do so, such as through building trust and open communication. A long history of medical racism in the U.S.

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DSCSA Compliance for Independent Pharmacies

DiversifyRx

Exploring the Drug Supply Chain Security Act (DSCSA) The DSCSA, signed into law in 2013, aims to heighten the security of the pharmaceutical supply chain by creating a framework for traceability and accountability. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain.