Frederick Ball

Frederick Ball

Duane Morris LLP

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FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S....more

8/5/2014 - Drug Manufacturers FDA GDUFA Generic Drugs Pharmaceutical Prescription Drugs

FDA Issues Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs. Specifically, the Guidance...more

6/19/2013 - CGMP Drug Manufacturers FDA FDCA Prescription Drugs Required Documentation

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