Articles by Maribel Rios - Pharmaceutical Technology

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Articles by Maribel Rios

Swine Flu Update

May 7, 2009

This week, pharmaceutical industry regulators and manufacturers moved quickly to address public health concerns regarding the outbreak and spread of H1N1 virus infection (swine flu). The following is an overview of key developments.

PhRMA Defends Sustainability and Waste Management Practices

Apr 30, 2009

The Pharmaceutical Research and Manufacturers of America released a statement this week in response to recent media reports regarding the amount of pharmaceutical ingredients being discharged by manufacturing facilities into the environment.

FDA Issues Guidance on Summaries for CTD-based Submissions

Apr 23, 2009

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).

EU, Health Canada Confirm Regulatory Cooperation

Apr 16, 2009

On April 2, the Health Products and Food Branch of Health Canada and EU (consisting of the European Commission [EC] and European Medicines Agency [EMEA]) released "Implementation Plan for Regulatory Cooperation on Medicinal Products."

PhRMA Elects New Board Chairman

Apr 9, 2009

The Pharmaceutical Research and Manufacturers of America (PhRMA) elected David Brennan, CEO of AstraZeneca, as board chairman.

Michigan Passes Law against Federal Preemption

Apr 2, 2009

On March 26, the Michigan House of Representatives passed House Bill 4316, effectively repealing part of a 1996 law that provides drug companies immunity from liability lawsuits involving products that have been approved by the US Food and Drug Administration.

Deep Freeze: Innovations in Lyophilization

By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.
Apr 2, 2009

By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.

Supreme Court Rules Against Wyeth in Federal Preemption Case

Mar 12, 2009

Ending a long, closely watched debate over the issue of federal preemption, the US Supreme Court on March 4, to uphold a $6.8 million Vermont Supreme Court decision of Diana Levine against Wyeth Pharmaceuticals (Madison, NJ).

Draft Guidance Issued for Drug and Biologics Labeling

Mar 5, 2009

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

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Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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