Articles by Erik Greb - BioPharm International

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Articles by Erik Greb

Abbott to Split into Medical-Products and Pharmaceuticals Companies

Nov 1, 2011

Last week, Abbott unveiled a plan to separate into two publicly traded companies, one focusing on diversified medical products and the other on research-based pharmaceuticals.

FDA Awards NIPTE Multimillion-Dollar Research Grant

Oct 18, 2011

Last week, FDA awarded a grant to the National Institute for Pharmaceutical Technology and Education (NIPTE) to improve drug development and manufacturing. The grant could be worth as much as $35 million over the next five years. Using the grant, NIPTE will conduct research in various areas, including methods for reducing time to market, enabling new performance attributes in drugs, improving small-batch production, and promoting continuous manufacturing.

FDA Proposes Enhancing Search Criteria for Inspections Database

Oct 11, 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.

FDA Publishes Guidance on Marketed Unapproved Drugs

Oct 4, 2011

Last week, FDA published a guidance titled 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 (OTC) drug review. The document is a revision of the June 2006 guidance of the same name

ISPE to Publish Updated Sterile-Product Manufacturing Guide

Sep 20, 2011

The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide, ISPE Baseline Guide: Sterile-Product Manufacturing Facilities, and contain practical information about technological advances in sterile manufacturing.

FDA Publishes Draft Guidance on Tablet Scoring

Sep 6, 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FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for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. The document also describes nomenclature and labeling, and is intended to facilitate the evaluation of these products.

ISPE Publishes Guide for Process Gases

Aug 9, 2011

Last week, the International Society for Pharmaceutical Engineering (ISPE) published a guidance document titled ISPE Good Practice Guide: Process Gases. The guide defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams (e.g., nitrogen, oxygen, argon, carbon dioxide, and compressed air).

WHO Predicts Flu-Vaccine Production Will Double by 2015

Aug 2, 2011

The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a presentation given by Marie-Paule Kieny, the World Health Organization?s (WHO) assistant director general for innovation, information, evidence, and research. Kieny spoke at the WHO?s first review of its Global Action Plan (GAP) for Influenza Vaccines on July 12?14, 2011. New manufacturers in 11 developing countries, including Brazil, India, Iran, Mexico, and Vietnam, will be producing vaccines by that time, according to the presentation.

FDA Bans Import of Drugs from Dr. Reddy's Mexico Site

Jul 19, 2011

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy?s Laboratories, according to Reuters. The import ban is a result of the company?s failure to correct the violations listed in a June 3, 2011, Warning Letter to the agency's satisfaction.

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