Regulatory Focus

New Physician Labeling to Be Required for Antibiotics

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

No votes yet

CPSC Proposes Child-Resistant Packaging for Certain OTC Drugs

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

No votes yet

New Requirements for Drugs in Cold Storage and Drugs in Semipermeable Packaging

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

No votes yet

ASTM Reorganizes Its Packaging Committee

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

No votes yet

New Labeling Guidance for OTC Drug Testing Kits

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

No votes yet

Rules Relaxed for Changes

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

No votes yet

Accelerated Aging Protocols Established

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

No votes yet

Disease Claims for Nutraceuticals

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

No votes yet

FDA Proposes New Monograph for Otic Drugs

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

No votes yet

Policy for Clinical Trial Packaging Takes Shape

CPSC allows latitude on some aspects of clinical trial packaging.

No votes yet
Syndicate content