It is well understood that regulations governing FDA approval to market pharmaceuticals are complex and ever changing. Meanwhile, the pressure is on pharmaceutical companies to adapt their strategies and transform their organizations to extend the value of existing drug products, develop niche drug products and otherwise create new sources of revenue. Developing a relationship with the right pharmaceutical consultant may minimize the time and resources necessary to achieve FDA approval of your NDA submission. PDG® is a global pharmaceutical and FDA regulatory affairs consultant with extensive experience in the strategic development of 505(b)(2) drug products. From identification and choice of viable candidates through ensuring the existence of cost-effective commercialization strategies, PDG is unique in its ability to comprehensively and ideally integrate dosage forms, disease states, populations and FDA regulatory pathways. The strategic drug development services team at PDG routinely and successfully presents client-proposed regulatory strategies and submissions to FDA that withstand review and scrutiny. Here are four important drug development areas where the regulatory expertise of PDG can be most beneficial:

  1. Fixed Dose Combinations (FDCs)

With increasing brand competition, FDCs represent lucrative lifecycle extension strategies and product differentiation opportunities. Note that 15% of FDA approved FDCs had achieved over a billion dollars in annual sales by 2014. FDA further added to the appeal of FDCs in 2014 with a new policy which, for the first time, will allow new fixed-dose combinations consisting of at least one new drug product to be eligible for five years of new chemical entity exclusivity. Under the eligibility clause, a drug is eligible for five-year NCE exclusivity if it is “a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other [505(b)] application”. The experts at PDG can help you navigate the FDA regulatory issues related to proving superior efficacy, safety, convenience or utilization using a synergistic FDC.

  1. Rx to OTC Switches

Rx to OTC switches and the corresponding repositioning from the prescription marketplace to the retail space represents huge market potential. The U.S. market for OTCs more than doubled between 2007 and 2013 growing from $16 billion to $33 billion and by 2014, an estimated 240 million Americans were using OTC medicines. Further, FDA’s recent Nonprescription Safe Use Regulatory Expansion initiative (NSURE), is reviewing a number of disorders and drug classes that hold promise for conversion to nonprescription status. PDG has years of experience assisting clients in the employment of the 505(b)(2) pathway to demonstrate adequate self-diagnosis, successful self-treatment, and safety and effectiveness under the conditions of actual use by consumers for the purpose of FDA approval for OTC use.

  1. Orphan Drugs

Although relatively small numbers of individuals have specific orphan disorders, the size of the overall population and high levels of reimbursement make orphan drugs an attractive option for the pharmaceutical industry. It has been reported that the worldwide orphan drug market could reach $127 billion by 2018, doubling that of the prescription drug market. Orphan designation qualifies the sponsor for various development incentives, including tax credits for qualified clinical trials, potentially seven years of exclusivity, and no user fees (unless the application includes an indication other than the rare disease or condition for which the drug was designated). PDG has experienced a substantial uptick in inquiries related to orphan drug development and routinely assists its clients in applying for orphan designation, followed by clinical development.

  1. Niche Products and the NDA Process

Repurposing, repositioning and reformulating previously approved drugs has proven to be highly successful among PDG clients. Specialty medications alone are expected to dramatically increase their share of the overall drug market over the coming decades. Specialty pharmaceutical spending at $55 billion in 2005 is projected to rise to $1.7 trillion by the year 2030. Pharmaceutical firms that seek to develop differentiated products without investing tens of millions of dollars will find the 505(b)(2) NDA submission to be an indispensable competitive mechanism.


The 505(b)(2) NDA submission is a powerful weapon in the regulatory arsenals of those firms in need of niche products and/or revenue streams pursued by fewer competitors in the short-term. One of the keys to success is the employment of strategic planning principles and a 505(b)(2) consultant with the depth of experience that PDG offers. 

Call +1.813.963.3062 or submit the form below, to explore how the strategic drug development services of PDG can help extend drug lifecycles and expand revenues for your firm.

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