Newsletter - August 31, 2023
FDA Releases Expectations for Using RWE in Support of New Drug Approvals
Real World Data (RWD) collected from medical records and the Real World Evidence (RWE) generated from it can be used to seek market approval for new uses of FDA-approved products by the FDA. However, there are specific FDA requirements for the quality and integrity of the RWD before its acceptance by the FDA...Read More
What You Should Know About the $1 Billion Taxpayer-Funded Covid Trial
The US government is investing heavily in finding new COVID-19 vaccines both to treat acute infections and to treat long-term side effects of Covid, called Long Covid. In that regard, the US Department of Health and Human Services (HHS) announced an award of $1.4 billion for its latest efforts of which $1 billion...Read More
FDA Releases Expectations for Using RWE in Support of New Drug Approvals
Real World Data (RWD) collected from medical records and the Real World Evidence (RWE) generated from it can be used to seek market approval for new uses of FDA-approved products by the FDA. However, there are specific FDA requirements for the quality and integrity of the RWD before its acceptance by the FDA...Read More
What You Should Know About the $1 Billion Taxpayer-Funded Covid Trial
The US government is investing heavily in finding new COVID-19 vaccines both to treat acute infections and to treat long-term side effects of Covid, called Long Covid. In that regard, the US Department of Health and Human Services (HHS) announced an award of $1.4 billion for its latest efforts of which $1 billion...Read More
