Pharmaceutical Consultant – Marketed Unapproved Drugs
FDA has long held the position that they are subject to take aggressive action against companies that market…
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Nanotechnology and FDA Regulation
Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated…
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FDA Risk Evaluation Workshop Announced
The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social…
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PDG to Attend RAPS Florida Chapter Meeting
Those of you who will be in central Florida this week are welcome to join PDG at an…
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Prescription to OTC: PDG Attends FDA Public Hearing on Expanded Access to Nonprescription Drugs
The agency held a public hearing on March 22-23, 2012 to “obtain input on a new paradigm we…
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PDG to attend FDA’s OTC Public Hearing
The agency recently announced a public hearing to “obtain input on a new paradigm we are considering.
Under…
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PDG to Attend RAPS Florida Chapter Launch Meeting
The Regulatory Affairs Professionals Society (RAPS) has announced that several regulatory professionals in Florida are interested in launching…
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Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)
FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees…
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Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced
According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food…
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Unapproved Drug Enforcement Policy Revised by FDA
On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs…
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