Drugs · Jul 10, 2026

Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.

1 extracted findings

FDA source excerpt, selected passage

You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Selected FDA passages, not the complete letter.

You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].

As cited in this historical letter, not a statement of current regulatory requirements.

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