Articles by Erik Greb - Pharmaceutical Technology

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Articles by Erik Greb

FDA Awards NIPTE Multimillion-Dollar Research Grant

Oct 13, 2011

Last week, FDA awarded a grant to the National Institute for Pharmaceutical Technology and Education to improve drug development and manufacturing. The grant could be worth as much as $35 million over the next five years.

FDA Proposes Enhancing Search Criteria for Inspections Database

Oct 6, 2011

FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011.

Reformulating Injectables for Oral Delivery

Could oral absorption-enhancing technologies change the shape of protein delivery?
Oct 2, 2011

Could oral absorption-enhancing technologies change the shape of protein delivery?

FDA Publishes Guidance on Marketed Unapproved Drugs

Sep 29, 2011

FDA has published a guidance on Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.

GE Healthcare to Invest $1 Billion in Oncology

Sep 22, 2011

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.

Can Redundant Filtration Make Sterility Assurance Double Sure?

Sep 21, 2011

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Sep 15, 2011

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

Regulators Debate Methods for Producing Water for Injection

Might European officials reverse their position on acceptable production methods?
Sep 2, 2011

Might European officials reverse their position on acceptable production methods?

FDA Publishes Draft Guidance on Tablet Scoring

Sep 1, 2011

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

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