Regulatory Focus

SPI Publishes Updated Guide to Regulatory Considerations for Drug Packaging Materials

The guide is designed to provide information useful to the entire pharmaceutical supply chain.

SPI: The Plastics Industry Trade Association is pleased to announce the publication of an update to its 2003 Guidelines for the Development of Type III Drug Master Files.  This manual, prepared by the SPI Pharmaceutical and Medical Device Applications Committee, is a guide to the regulatory considerations and procedures to be taken into account when establishing a Type III Drug Master File.  The new updates reflect procedural changes at the U.S. Food and Drug Administration and "best practices" amassed by the law firm of Keller and Heckman.

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Report: Falling European Drug Prices to Drive Down Healthcare Costs

A study from GBI Research outlines drug pricing in five European countries and how regulatory mechanisms could affect the drug and pharmaceutical packaging industries.

Reportlinker.com announces that a new market research report is available in its catalog: Drug Price Cuts in Top Five Countries of Europe - Tougher Reference Pricing Environment and Drug Price Freeze through 2013 Expected to Drive Down Healthcare Costs.

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Foley Hoag’s new health care policy blog – a healthy dose of policy analysis

The recent passage of healthcare reform legislation is by no means the end of the debate over how to overhaul the U.S. healthcare system. Indeed, the real fireworks may just be beginning.


To help industry watchers and participants stay current with the reform bill’s enormous implications across multiple sectors, law firm Foley Hoag has launched a new blog with up-to-date postings on the legal, policy, and regulatory features of the changing healthcare and life sciences landscape.

FDA Proposes to Delete Warning Label on Hormone

FDA finds that there is no reliable evidence showing that drugs with progesterone cause birth defects.

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FDA's Bar Code Rule

FDA's proposed bar code rule for prescription and OTC drugs used in hospitals aims to prevent medication errors.

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Tighten Foreign Inspections

A petition to FDA calls for clearer inspection policies. Until then, consumers may have to scrutinize such imported products as toothpaste.

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Tighten Foreign Inspections

A petition to FDA calls for clearer inspection policies. Until then, consumers may have to scrutinize such imported products as toothpaste.

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Tighten Foreign Inspections

A petition to FDA calls for clearer inspection policies. Until then, consumers may have to scrutinize such imported products as toothpaste.

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ISTA Issues Thermal Packaging Guideline

Document outlines test for insulated transport packages.

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Tighten Foreign Inspections

A petition to FDA calls for clearer inspection policies. Until then, consumers may have to scrutinize such imported products as toothpaste.

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