Articles by Maribel Rios - Pharmaceutical Technology

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Articles by Maribel Rios

FDA Releases Draft Guidance for OTC Labeling

Dec 18, 2008

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an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.

FDA Releases Guidance on Cooperative Manufacturing for Biologics

Dec 11, 2008

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

Terror Attacks Postpone Mumbai Conference and Raise Concern over Outsourcing

Dec 4, 2008

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.

GMP Final Rule Takes Effect

Dec 4, 2008

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

Is Job Security Throwing You Off Balance?

Results from Pharmaceutical Technology's Annual Employment Survey
Dec 2, 2008

Results from Pharmaceutical Technology's Annual Employment Survey.

GPhA Applauds FTC Biogenerics Roundtable while Biotechs Fall

Nov 26, 2008

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.

Supreme Court, PhRMA Present Arguments on Preemption

Nov 6, 2008

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."

A Fresh Coat: Innovation in Excipients

Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.
Nov 2, 2008

Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.

IPEC's New Safety Evaluation Procedure: A Q&A with IPEC Chairman Dave Schoneker

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.
Nov 2, 2008

IPEC Chairman Dave Schoneker discusses current efforts toward facilitating regulatory reviews of new excipients.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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