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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Uncharted Waters: Potential Regulatory Impacts of Coronavirus (COVID-19) on Pharma and Biotech Industries

With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of 10 Years of Additional Study Results

The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may need to post certain study results for 10 years’ worth of clinical trials (2007–2017), which the US Department of Health and Human Services (HHS) had previously excluded from the requirement.

A Tale of Two Studies: FDA Releases Draft Guidance on Demonstrating Efficacy with a Single Study

FDA issued a draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products (Draft Guidance), on December 19, 2019, as an expansion of its 1998 guidance, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998 Guidance).