Hardware Podcasts

219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

Let's Combinate · 24 Dec 2025 · 25m

What this episode covers

Host Subhi Saadeh and guest Ben Locwin discuss the FDA's evolving approach to Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs), focusing on the industry's push to decouple inspection timing from approval decisions to avoid Complete Response Letters (CRLs). They analyze the FDA's new PreCheck program, designed to accelerate the regulatory review of onshored pharmaceutical manufacturing facilities, and compare US regulatory strategies with those of the EMA and MHRA.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Eli Lilly, J and J, Merck, EMA, MHRA
Also
PreCheck, Complete Response Letter, DMF Type 5

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