Dec 18, 2008
By:
Maribel Rios
The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.
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Dec 11, 2008
By:
Maribel Rios
The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.
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Dec 4, 2008
By:
Maribel Rios
FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.
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Dec 4, 2008
By:
Maribel Rios
Industry experts are predicting that last week?s terror attacks in Mumbai, India may have at minimum some short-term effects on the pharmaceutical industry outsourcing business in that region.
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Results from Pharmaceutical Technology's Annual Employment Survey
Dec 2, 2008
By:
Maribel Rios
Results from Pharmaceutical Technology's Annual Employment Survey.
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Nov 26, 2008
By:
Maribel Rios
During its roundtable discussion titled "Follow-On Biologic (FOB) Drugs: Framework for Competition and Continued Innovation," The Federal Trade Commission (FTC) discussed likely effects, patent issues, and regulatory exclusivity periods concerning FOBs.
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Nov 6, 2008
By:
Maribel Rios
Arguments in the Supreme Court case Wyeth v. Levine have concluded, leaving both sides to wait possibly until early 2009 for a decision in a preemption case involving the misadministration of Wyeth's "Phenergan."
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Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.
Nov 2, 2008
By:
Maribel Rios
Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.
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IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.
Nov 2, 2008
By:
Maribel Rios
IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.
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