The Regulatory Affairs Professionals Society (RAPS) has announced that several regulatory professionals in Florida are interested in launching a RAPS Chapter. PDG is pleased to inform our readers that we will be joining RAPS for the inaugural meeting to interact with other regulatory professionals from our area. The meeting will be held in Tampa on…
FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors. As currently drafted, a one-time backlog fee is anticipated for “Each person that owns an abbreviated new drug application (ANDA) that is pending on October 1, 2012, and that has not received a tentative…
According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the-counter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which…
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 has extensive experience in the development of drug/device combination products and combination drug therapies, including all IND and NDA requirements for both fixed-dose combinations or co-packaged drugs.
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,…