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…
Continue reading
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…
Continue reading
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…
Continue reading
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…
Continue reading
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…
Continue reading
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…
Continue reading
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…
Continue reading
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…
Continue reading
Generic Pharmacovigilance/Safety Surveillance & CBEs
As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues.…
Continue reading
Generic drug manufacturers could face new regulatory requirements from FDA
FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to…
Continue reading