ipec Weekly Update MultiBriefs

Coalition Calls for Science-Based Approach to Elemental Impurity Testing

David Schoneker, a chairman for the Coalition of Rational Impurities Requirements said that industry is concerned by a May 2014 deadline set by USP for implementing its General Chapters on elemental impurities while ICH is working...

source: In-PharmaTechnologist.com
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David Schoneker, a chairman for the Coalition of Rational Impurities Requirements said that industry is concerned by a May 2014 deadline set by USP for implementing its General Chapters on elemental impurities while ICH is working...

source: In-PharmaTechnologist.com

In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500 million after pleading guilty to manufacturing and distributing adulterated drugs, according to the U.S. Justice Department settlement agreement. The company plead guilty to three...

source: in-PharmaTechnologist.com

Once famously described as "orphan diseases, too small to be noticed, too small to be funded" in the Hollywood drama Lorenzo's Oil, rare diseases are getting unprecedented attention among drug manufacturers, who are ramping up research...

source: Medical News Today

US Food and Drug Administration (FDA) has now issued guidance on Regulatory Classification of Pharmaceutical Co-Crystals. It provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on the...

source: Pharmabiz.com

The 2013 PDA/FDA Pharmaceutical Supply Chain Workshop will explore and address the benefits of modernization and innovation, as well as the ongoing challenges of supplier and contractor management. The workshop will also...

source: IPEC-Americas

The United States Pharmacopeial Convention (USP) will be holding the first Excipients Stakeholder Forum on June 7, at USP's Rockville, Md., headquarters. To expand the opportunity for stakeholder participation, USP will...

source: IPEC-Americas

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