DIA: Driving Insights to Action
Science:Life Sciences
In late March 2020, FDA issued Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency: Guidance for industry investigators and institutional review boards. In the agency statement accompanying its release, FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah stated, "FDA released this guidance to emphasize that at all times patient safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants."
HHS Final Rule: Good Data Shared Well Leads to Great Science
Patient Partners: Power That Rests in Us All
Technology & Data Driving Europe’s ClinOps Forward
CFDA Joins ICH, Seeks Public Comment on Further Reforms
New DIA Forum to Align Regulatory & ClinOps Expectations
Different Roots, Shared Fruits: FDA-EMA Collaboration
RWE: Bridge Between Clinical Research & Practice?
Progress in Pediatric Therapeutics Bigger Than “Smaller Dose”
Is Drug Repurposing Really As Promising As It Seems?
More Than Socially Fair or Economically Just – It’s Better Science
New China-Denmark Food & Drug Regulatory Cooperation Centre
ABPI Sees Brexit as One Game of Two Halves
Europe’s IMI Helps Drive New R&D and Access Models
Lack of Access Can Lock Patients in “Disease of Despair”
Can We “Pay for Results” to Sustain Innovation?
Uncertainty is Certain: Pandemic Vaccine Preparedness
Where and How to Bridge the EU Biotech Funding Gap
Transparency Essential to Payers’ New Role in EU
EBE Plots Path from “Flawed Underfunded Biotech System”
RCT & RWE: Evolution, Revolution or Integration?
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