Regulatory Focus

FDA wants to use labeling to combat overuse of systemic antibiotics, which it says increases resistance among microorganisms.

All oral prescription drugs that switch to OTC would be subject to the commission's CR packaging requirements.

A new FDA document outlines stability data requirements for new molecular entities and related drugs.

Anticipating PACPAC, the society realigns its members to prepare for future standards work.

FDA specifies what a kit's labeling must say if it is to be marketed without prior agency approval.

In many cases, postapproval packaging changes will no longer have to be approved by FDA prior to implementation.

ASTM's new standard shows how to set up and conduct an accelerated aging test.

A bill in the House would protect petitioners' disease claims for 10 years.

Topical OTC drugs used for treating or preventing water-clogged ears would get their own labeling rules.

CPSC allows latitude on some aspects of clinical trial packaging.