May 7, 2009
By:
Maribel Rios
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.
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Apr 30, 2009
By:
Maribel Rios
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.
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Apr 23, 2009
By:
Maribel Rios
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).
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Apr 16, 2009
By:
Maribel Rios
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."
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Apr 9, 2009
By:
Maribel Rios
The Pharmaceutical Research and Manufacturers of America (PhRMA) elected David Brennan, CEO of AstraZeneca, as board chairman.
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Apr 2, 2009
By:
Maribel Rios
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.
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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:
Maribel Rios
By reducing cycle time and implementing quality-by-design inspired engineering, advanced lyophilization systems are driving the industry toward greater efficiency and control.
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Mar 12, 2009
By:
Maribel Rios
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).
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Mar 5, 2009
By:
Maribel Rios
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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