FDA has long held the position that they are subject to take aggressive action against companies that market drugs they consider unapproved. FDA’s most recent notice to industry stated that “any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard…
Those of you who will be in central Florida this week are welcome to join PDG at an FDA presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media” on May 24th, 2012, 5:30–8:30 pm at the Hampton Inn and…
On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs – Compliance Policy Guide, replacing the version previously released in June 2006. This guidance represents a shift in FDA’s approach to enforcement actions related to marketed drugs without approved NDAs, ANDAs or OTC monograph compliance. To learn…
PDG assists the pharmaceutical industry to develop and maintain prescription and non-prescription drug products and devices. Not surprisingly, we engage in a variety of regulatory activities involving literature searches and data evaluations to accomplish these tasks. On any given day you might find our staff developing Pre-IND/NDA meeting packages, developing FDA correspondence and regulatory submissions,…