FDA Law Blog

SEPTEMBER 10, 2023

By Mark A. Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program. This finalized a draft guidance issued in December 2021, largely similar in substance.

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Trialfacts

SEPTEMBER 10, 2023

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center: Location Research Center: Pediatric Skin Research LLC Location: 4425 Ponce De Leon Blvd Suite 115, Coral Gables, FL 33146 Lead Researcher: Mercedes E Gonzalez, MD IRB: This study has been reviewed and approved by the WCG Institutional Review Board About the Study There are limited options for CSU (Chronic Spontaneous Urticaria) for children between the ages of 2 and 12.

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Cloudbyz

SEPTEMBER 10, 2023

The challenge of managing and securing sensitive data, including PHI and PII, is significant for life sciences organizations. The volume of data that these organizations collect and process is growing rapidly, making it difficult to manage and protect. At the same time, the regulatory environment is becoming increasingly complex, with new data protection regulations being introduced regularly.

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JAMA Internal Medicine

SEPTEMBER 10, 2023

This JAMA Internal Medicine Patient Page describes details of palliative care, including who it can benefit and when it should be considered.

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Medicine 103

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Drug Patent Watch

SEPTEMBER 10, 2023

Annual Drug Patent Expirations for VIBATIV Vibativ is a drug marketed by Cumberland Pharms and is included in one NDA. It is available from one supplier. There are two patents… The post New patent expiration for Cumberland Pharms drug VIBATIV appeared first on DrugPatentWatch - Make Better Decisions.

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JAMA Internal Medicine

SEPTEMBER 10, 2023

This case report presents the electrocardiogram findings of a patient in their 50s with severe COVID-19 pneumonia, hypertension, and diabetes.

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Drug Patent Watch

SEPTEMBER 10, 2023

Annual Drug Patent Expirations for LONSURF Lonsurf is a drug marketed by Taiho Oncology and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Taiho Oncology drug LONSURF appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

SEPTEMBER 10, 2023

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Sweden. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Sweden? appeared first on DrugPatentWatch - Make Better Decisions.

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