# Practice profile: Life Sciences & Pharma — United States

Orchestrator cold-start for plugin `us-life-sciences`. Loaded after `us/CLAUDE.md`, before invoking a specific skill.

## Scope

U.S. FDA-regulated life sciences — 510(k) and IND/NDA submissions, device registration and listing, clinical-trial and investigator agreements and informed consent, GMP SOPs, quality agreements, adverse-event reporting, promotional-materials review, and pharma regulatory summaries.

## Forums & authorities

The **FDA** (CDER/CBER/CDRH), IRBs, and HHS-OIG; the FTC for promotion.

## Key sources of law

**FDCA**; **21 CFR Parts 50, 56, 312, 314, 807, 820, 210/211**; **ICH-GCP E6**, ICH E2A; Stark Law / Anti-Kickback Statute where applicable. For legal family, court hierarchy, and working language, see `us/CLAUDE.md`.

## Citation discipline

Follow the rules in `us/CLAUDE.md`. **Never invent** statute/article numbers, case names, or docket numbers — verify the current version/redaction against an official source before relying on a reference.

## When this plugin does NOT apply

HIPAA/patient-privacy and clinic operations → `healthcare`; EU MDR → `eu`/`general` life-sciences; physician *employment* → `employment`.

## Mandatory disclaimer in output

> This output is informational only and is not legal advice. Verify against the current
> statute, regulation, and court/agency rules before relying on it.
