India’s Pharma Industry Faces Unprecedented Challenges
India’s pharmaceutical industry has grown at record levels in recent years…
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US Pharmaceutical Consultant on India’s Pharmaceutical Industry and the Decline of the Patent Cliff
PDG: A Pharmaceutical Consultant on Drug Reformulation
As a pharmaceutical consultant, PDG understands that today’s drug manufacturers rely upon reformulation to prolong product lifecycles, protect…
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Rx-to-OTC Switches Represent Huge Market Potential
Rx-to-OTC switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail (over-the-counter or…
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Orphan Drugs – Opportunities & Issues
Orphan Drugs Offer Revenue and Profit Upside
Many have speculated that the era of the blockbuster drug has…
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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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FDA Delays Publication of Generic Drug CBE Rule Until Fall 2015
In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that…
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RAPS Reports Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal
PDG™ is a pharmaceutical consultant serving drug sponsors around the world. On July 28, 2014, PDG™ published a…
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FDA Grants AB Rating to 505b2 NDA Generic
FDA recently granted a therapeutic equivalence (TE) rating of AB to a “generic” version of an innovator product…
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Generic Pharmacovigilance/Safety Surveillance & CBEs
As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues.…
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Strategy and Development
PDG provides pharmaceutical strategy and development consulting expertise and serves as our clients’ regulatory voice at FDA. Whether you require a 505(b)(1) or 505(b)(2) NDA, PDG employs pharmaceutical industry professionals who routinely and successfully present client-proposed regulatory strategies to the Agency.
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