FDA

Eric Greenberg
Column/Opinion
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Sunscreens: follow FDA specs or get burned

You know what’s great about modern healthcare?
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Drug compounding
News
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FDA issues guidance for outsourcing facilities

On Nov. 21, 2014, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities.
Kevin O'Donnell is Vice President, Cold Chain Standards, Practices & Compliance at BioLife Solutions, Inc., and is a Contributin
Column/Opinion
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Test your cold chain IQ

True or false questions about the handling of biologics and drugs in the supply chain.
Dirk Rodgers is a Contributing Editor for Healthcare Packaging and author of RxTrace.
Column/Opinion
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DSCSA answers are needed

FDA is not addressing the questions people are asking.
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Column/Opinion
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What is considered a drug?

FDA Warning Letters provide reminder of the basics of drug regulation.
VIAL STOPPER. This image shows a continuous ink-jet code on a vial stopper.
Feature Article
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Comparing UDI and DSCSA coding

Although there are differences between the medical device Unique Device Identification (UDI) regulation and the Pharmaceutical Drug Supply Chain Security Act (DSCSA), Videojet Technologies’ Tim Kearns finds many common aspects across both.
Column/Opinion
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Packaging and its partners

When packagers speak of packaging, frequently they are referring to the physical structure holding a product.
Source: U.S. Food and Drug Administartion, “Pregnancy and Lactation Labeling Final Rule,” 12/3/14
News
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FDA updates drugs/biologics labeling system

Includes major revisions on pregnancy and breastfeeding, with labeling changes taking effect June 30, 2015. Prescription drugs and biologic products approved after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015
News
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DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015

Topics to be covered March 3-5, in Virginia Beach will include technology for manufacturing innovation, package design, sealing process validation, and a local operating nurse panel.
Column/Opinion
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An interesting rulemaking, if you like that sort of thing

In today’s column, I try to persuade you that the way FDA has lately been making regulations is unusual, surprising, and interesting.

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