Proposed Generic Drug Labeling “CBE” Rule Turned on its “EAR”?

Changes Being Effected (CBE) As pharmaceutical consultants, PDG has reported extensively on FDA’s Proposed Rule entitled Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. We even gave it our own abbreviated name: the “Generic CBE Rule”. We did so because the rule as originally proposed would allow generic manufacturers to implement safety…

US Pharmaceutical Consultant on India’s Pharmaceutical Industry and the Decline of the Patent Cliff

India’s Pharma Industry Faces Unprecedented Challenges  India’s pharmaceutical industry has grown at record levels in recent years but now faces unprecedented challenges as the number of blockbuster drugs scheduled to go off patent begins to decline. As Indian pharma has expanded ANDA filings in line with the patent expiration cycles over the last decade, the…

Clinical Trial Design

Clinical Trial Design

PDG designs and executes preclinical and clinical (Phases I-IV) programs associated with pharmaceutical product development and the securing of FDA approvals for both brand name and generic drug products. Our experienced and professional staff of pharmaceutical scientists and regulatory experts will help you navigate study design challenges across a wide variety of designs. These include,…