FDA Issues Draft “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”


On January 13, 2014, the Food and Drug Administration (“FDA”) issued its draft “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” (the “Guidance”). Although it contains nonbinding recommendations, this long-awaited draft Guidance provides pharmaceutical drug and biologics manufacturers with the FDA’s current thinking on how to fulfill their post-marketing regulatory requirements for submission of “interactive promotional media” as it relates to their FDA-approved products. [Read more...]

Beyond Gender Bias–Lessons from the Female Libido Drug’s Path To Approval

Female libido drug candidate flibanserin has rekindled a debate about gender bias in the Food and Drug Administration’s drug approval process. The debate centers on that agency’s approval of 24 drugs to treat male sexual dysfunction and its failure to approve even one drug to treat female sexual dysfunction. While commentators and politicians debate alleged gender bias at a federal agency headed by a woman, the flibanserin story provides important lessons for pharmaceutical and biotech companies that run into obstacles along the path toward approval.
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FDAAA 2007: Clinical Trials Disclosure – Common Mistakes in Compliance


The Food and Drug Administration (FDA) is the primary enforcement agency of human subject protection in the United States. With its gatekeeping role over medical products and statutory authority with an established inspection force, the FDA is undeniably a powerful player in regulating clinical research. In September 2012, the US Department of Health & Human Services (HHS) transferred authority from HHS control to the FDA to oversee information that is filed to ClinicalsTrials.gov (“clinical trial registry data bank”), and seek out those who fail to file, or file misleading or false data, according to a statement in the Federal Register (Note: ClinicalTrials.gov is mandated under U.S. Public Law 110-85 (Food and Drug Administration Amendments Act “FDAAA” of 2007), Title VIII, Section 801).
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