Writing

Thoughts, notes and notebooks.

Writing by Abhishek (Abhi) Pratap on clinical development, digital health, AI and regulatory science.

Illustration of a prescription bottle next to a phone showing a medication app

FDA Final PDURS Guidance: Paving the Way for Drug + Digital ClinDev Strategy

regulatory

digital health

clinical development

FDA’s final guidance on prescription drug use-related software treats sponsor-provided companion apps as drug labeling. Early thoughts on evidence planning and the drug lifecycle.

Nov 1, 2026

Abhishek (Abhi) Pratap

Illustration on bias and equity in digital health

Digital health - keeping bias and equity at the front and center

AID4MH

Why bias and equity need to be at the front and center of digital health research and care.

Mar 28, 2022

Aditi Surendra & Abhishek Pratap

Assessing real-world mental health outcomes with wearables

Wearables

Wearable Operations - Deploying wearables in real-world settings - decentralized research, digital health

Mar 17, 2022

Ramzi Halabi, Ava Homiar, Ethan Kim, Adeel Ansari, Aditi Surendra, Sophie Lafaille, Joanna Yu, David Rotenburg, Sean Hill, Abhishek Pratap

Categories

FDA Final PDURS Guidance: Paving the Way for Drug + Digital ClinDev Strategy

Digital health - keeping bias and equity at the front and center

Assessing real-world mental health outcomes with wearables