JD Supra

FDA Proposes New Drug Manufacturing Rule: What Distributed Manufacturing and Foreign API Registration Changes Could Mean for Pharma Compliance

In the wake of the Food & Drug Administration’s (FDA) ambitious unified agenda, on July 13, 2026, the agency published a proposed rule aiming to align its regulatory frameworks with “how distributed ...

Dr. Oregonin Completes U.S. FDA Registration for OLTIS DENTAL-X, Unveiling Oral-Care Innovation Rooted in Trans-Pacific Alder Research

Dr. Oregonin Inc. today announced that it has completed U.S. Food and Drug Administration (FDA) registration for OLTIS DENTAL ...
RAPS

FDA Selects Unique Facility Identification System for Registration of Drug Facilities Under FDASIA

A new cross-center draft guidance document released by the US Food and Drug Administration (FDA) established the agency's preferred unique facility identification (UFI) system used to register ...
arcweb

U.S. FDA Proposes Updated Registration Framework for Distributed Drug Manufacturing

Proposed changes would streamline hub-and-spoke manufacturing registration and improve visibility into foreign pharmaceutical supply sources. The U.S. Food and Drug Administration (FDA) has proposed a ...
FiercePharma

FDA floats possible approach to repurpose approved drugs under new uses

The FDA is seeking public comments on drugs that could be candidates for a new use through its reurposing initiative. The FDA is looking to get thrifty with its approved drugs. Through a newly ...
Tobacco Reporter

FDA Streamlines Tobacco Product Registration and Listing Process

The redesigned form streamlines the filing and allows companies updating existing registrations to change specific ...
Boston Herald

FDA proposes new system for approving customized drugs and therapies for rare diseases

WASHINGTON (AP) — Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions ...