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2001
FDA Clarifies Postapproval Changes (PMPN)
The agency has published a guidance document answering some of the most frequently asked questions on postapproval changes for drugs.
FDA Caters to Physicians (PMPN)
A proposed rule for redesigning prescription drug labeling can help save physician time and reduce adverse drug events.
FDA Sheds Light on Drug Labeling (PMPN)
Two published guidances aim to clarify presentation issues with over-the-counter drug labeling.
FDAMA Makes Favorable Progress (PMPN)
A report from FDA reveals successful efforts to educate patients and healthcare professionals, plus increased electronic filing and the development of regulations to promote clarity in labeling.
 
2000
New Criteria for Disease-Related Claims on Dietary Supplement Labels (PMPN)
FDA uses new guidelines to authorize and deny health-related claims.
New Physician Labeling to Be Required for Antibiotics (PMPN)
FDA wants to use labeling to combat overuse of systemic antibiotics, which it says increases resistance among microorganisms.
New Requirements for Drugs in Cold Storage and Drugs in Semipermeable Packaging (PMPN)
A new FDA document outlines stability data requirements for new molecular entities and related drugs.
New Format for Device Labeling (PMPN)
Labeling intended for patients must now be formatted so that it is easy to understand and follow.
FDA Issues Rule on Aluminum in Parenteral Packaging (PMPN)
The agency mandates labeling and testing for aluminum-containing products used for total parenteral nutrition therapy.
Rules Relaxed for Changes (PMPN)
In many cases, postapproval packaging changes will no longer have to be approved by FDA prior to implementation.
 
1999
Medical Packaging Roundtable: Managing ISO 11607 (PMPN)
It has been more than a year since FDA recognized as an official guidance the standard ANSI/AAMI/ISO 11607: 1997, "Packaging for Terminally Sterilized Medical Devices." Although the document is not an exact checklist specifically stating the steps to validating packaging and packaging processes, many in the medical device industry have welcomed it.
FDA Proposes New Monograph for Otic Drugs (PMPN)
Topical OTC drugs used for treating or preventing water-clogged ears would get their own labeling rules.
FDA Explains Labeling Regulations (PMPN)
The agency plans to launch a Web site that will give users information about handling exemption requests, bar codes, and small packages.
NDAs Require Packaging Data (PMPN)
FDA outlines what packaging data are expected in an application and puts forth suitability and quality control standards.
FDA Proposes to Delete Warning Label on Hormone (PMPN)
FDA finds that there is no reliable evidence showing that drugs with progesterone cause birth defects.
FDA Finalizes OTC Labeling Format (PMPN)
Changes are intended to make labels easier to read and understand.
Guidance for Geriatric Labeling (PMPN)
Supplements intended to clarify geriatric drug use.
Extra Labeling for Certain Drugs (PMPN)
The new rules will apply to drugs used by children and to those posing a significant health concern.
Sealed Two-Piece Capsules Mandatory (PMPN)
Only one tamper-evident packaging feature now required.
 
1998
The New FDA: What You Need to Know (PMPN)
The new law has implications for labeling.
FDA Wants New Warnings on Laxative Labeling (PMPN)
FDA hopes warnings will reduce laxative overdoses, which, the agency claims, can be fatal.
FDA Clarifies Labeling Claims for Dietary Supplements (PMPN)
FDA proposes nine ways to distinguish between structure and function claims, which are legal, and disease claims, which are not.
Proposed Ruling Affects OTC Ophthalmic Drug Manufacturers
Complaints prompt FDA to consider requiring new warnings on product labeling.
Aluminum Content Warnings Proposed for TPN Therapy Products (PMPN)
Aluminum levels in total parenteral nutrition therapy products have triggered a proposed requirement.
FDA Modernization Act Recognizes the Importance of Standards (PMPN)
Legislation allows companies to declare conformity to voluntary standards.
FDA Reform Act Has Minimal Effect on Packaging (PMPN)
The act speeds the approval process for changes to drugs, devices, and biologic manufacturing, among other things, but has little to say about labeling or packaging.
Comment Period Closes for Medical Device Labels (PMPN)
Now that the deadline has passed, CDRH can finalize labeling guidelines for new devices.