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Ensuring the Safety and Efficacy of Clinical Trials

Perficient: Drug Development

CLIENT An American multinational corporation that develops medical devices, pharmaceuticals, and consumer packaged goods. PROJECT BACKGROUND Since 2008, Perficient has delivered multiple infrastructure platforming, commerce, and management consulting projects for this multinational corporation.

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Discovering an Antimalarial Drug in Mao’s China

Codon

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. When Louis Miller, now Chief of Malaria Cell Biology at the NIH, attended a malaria conference in Shanghai in 2008, he asked: Who discovered artemisinin? Nobody had an answer.

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Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Agency IQ

Regulation (EC) No 1234/2008 (Variations Regulation) provides the procedures for implementing the different types of variations. That same year, the Pharmaceutical Strategy for Europe called for a revision of the Variations Regulation and an evaluation of the existing legislation. could benefit both industry and regulators.

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Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Agency IQ

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. Circuit granted EPA a voluntary remand in 2008 for the Agency to re-evaluate the MACT floors established in 1995 based on the D.C. EPA, 358 F.3d 3d 936 (D.C.

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Transitioning to eCTD v4.0

The Premier Consulting Blog

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). the current default version internationally, was established in 2008. Implementation Package v1.5 Implementation Package v1.5

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Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

Section 2008 Improved Consumer Confidence Reports amended the Safe Drinking Water Act section 1414(c)(4) to revise requirements for Consumer Confidence Reports (CCR). EPA recently reclassified several areas as Severe nonattainment areas for the 2008 ozone NAAQS. These areas include Dallas-Fort Worth, TX, Denver-Boulder-Greeley-Ft.