Omnipresent Literature Searches and Data Review Assignments
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...
View ArticleFDA Risk Evaluation Workshop Announced
The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The...
View ArticleRecent FDA Presentation on Advertising, Promotional Compliance, Social Media...
Recently, representatives from PDG attended the second meeting of the Central Florida chapter of RAPS. Featured was a presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug...
View ArticleA Regulatory Affairs Consultant’s eCTD Update
According to the Regulatory Affairs Professional Society (RAPS), the “The eCTD has become the standard for many regulatory agencies around the world.” FDA’s CDER and EMA have mandated eCTD...
View ArticleCombination Drug Development and Five Year New Chemical Entity (NCE) Exclusivity
FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity. [1] FDA explained that it has revised its interpretation of the term...
View ArticleHelp With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and...
As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their BPCA and PREA needs. This...
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