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Assessing COVID-19 Symptoms in Clinical Trials

The onset of the coronavirus, or COVID-19, created havoc across the globe since its emergence in December 2019 in Wuhan, China, and fast spreading potential. Though no longer considered a “public...

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Essential Aspects of Labeling for Clinical Supplies and Investigational Products

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Harmonization for the Development of Cell and Gene Therapies

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How is Team AB Gearing up for the new MedTech Legislation?

In the development of the UK’s medical device industry, a consortium of Approved Bodies (AB) united under the banner of the UK Association for Medical Device Approved Bodies, or simply, Team-AB. This...

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DDReg Opens Entity in Singapore

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Empowering Rare Disease Drug Developers

Advanced rare disease drug developers are companies or organizations that specialize in the research and development of treatments for rare diseases. Developing drugs for rare diseases poses unique...

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Commitment to Biological Product and Patient Safety in India

Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives.  Thus, these...

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CMC Considerations for Human Gene Therapy INDs

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Controlled Correspondence for Generic Drug Development

Regulatory agencies across the globe are committed to ensuring that patients and the public have timely access to safe, effective, and high-quality medicines. They make significant developments, be it...

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Conducting Clinical Trials for Investigational Products in Brazil

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