Help With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and Waiver Requests
As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by…
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Combination 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…
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A Regulatory Affairs Consultant’s eCTD Update
According to the Regulatory Affairs Professional Society (RAPS), the “The eCTD has become the standard for many regulatory…
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Recent FDA Presentation on Advertising, Promotional Compliance, Social Media Helpful and Informative
Recently, representatives from PDG attended the second meeting of the Central Florida chapter of RAPS.
Featured was a…
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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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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…
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