Regulatory

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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Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Column/Opinion
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Navigating FDA recall requirements

A medical device recall by any other name might still stink for your company.
Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity.
Column/Opinion
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Reevaluating drug product stability can save millions on packaging

Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.
FDASIA strengthens agency’s authority
News
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FDASIA strengthens agency’s authority

Reviewing provisions of the legislation that impact drug product inspections.
GS1 US has published a guideline that details how to implement GS1 Standards to support the 2013 Drug Supply Chain Security Act (DSCSA), and enhance patient safety and security in the pharmaceutical supply chain. (This photo is for illustration purposes only.)
News
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Guideline delineates how to implement GS1 standards

Document provides intelligence to support pharmaceutical lot-level management and future item-level traceability requirements
FDA’s growing global focus faces language barriers
Column/Opinion
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FDA’s growing global focus faces language barriers

As FDA becomes more globally focused, drug complaints and adverse event reporting pose “cultural” challenges, as do inspections.
PDA developing Technical Report on drug shortages
News
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PDA developing Technical Report on drug shortages

Parenteral Drug Assn. expects to publish report on the prevention and management of drug shortages by early 2015.
Healthcare Packaging Publisher Jim Chrzan.
News
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FDA continues to stress manufacturing excellence

PDA/FDA Joint Regulatory Conference says global supply chain will require unprecedented cooperation.
Desmond Hunt, Ph.D., Senior Scientific Liaison, U.S. Pharmacopeial Convention (USP)
Column/Opinion
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USP to roll out information chapters on Good Distribution Practices

Five new general chapter standards related to GDP to become official next year, when three new chapters will be proposed.
PDA’s Universe of Pre-filled Syringes & Injection Devices Conference and Exhibition will be held October 6-7 at the Hyatt Regency Huntington Beach, CA. The exhibit hall will be open from 9:45 a.m. to 4:00 p.m. on Monday, Oct. 6, and from 9:45 a.m. to 4:00 p.m. on Tuesday, Oct. 7. For more information, contact PDA at 301/656-5900.
News
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Universe of pre-filled syringes and injection devices

Parenteral Drug Assn. conference and exhibition features top packaging companies.

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