It has been my experience that even the most experienced drug development and pharmaceutical consultants will stumble over the definitions of, and differences between FDA’s four expedited programs. Included among them are accelerated approval, priority review, fast track, and breakthrough therapy.[1] This paper is designed as a primer to increase understanding of the expedited programs,…
PDG™ is comprised of pharmaceutical consultants who devote considerable resources to brand and generic post-marketing safety surveillance, pharmacovigilance and labeling supplements. On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using the Changes Being Effected (CBE) and Prior-Approval Supplement (PAS) procedures (among…
What is an Adaptive Clinical Trial? Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design. Gaining in popularity since the early 1990s,[1] adaptive trials are those which observe patient outcomes after review of interim data and accommodate modifications to trial and/or statistical procedures.[2] [3] [4] Compare such trials…
As a medical device consultant, PDG takes great interest in the ever-changing landscape of the premarket notification (510(k)) review and clearance process. Besides the significant scrutiny given to the program over the past five years, the vast majority of legally marketed medical devices in use in the U.S. today were cleared via the 510(k) regulatory…
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…
As a pharmaceutical consultant, PDG understands that today’s drug manufacturers rely upon reformulation to prolong product lifecycles, protect against generic competition, supplement dwindling pipelines and otherwise differentiate/repurpose existing drug products. Indeed, novel formulations and drug delivery-based product development strategies have the potential of yielding higher returns on investment than comparable repositioning strategies. The Value of…
Rx-to-OTC switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail (over-the-counter or OTC) drug space represent huge market potential. A Strong Domestic OTC Market The U.S. market for OTCs more than doubled between 2007 and 2013 growing from $16 billion to $33 billion. [1] By the beginning of 2014,…
Orphan Drugs Offer Revenue and Profit Upside Many have speculated that the era of the blockbuster drug has ended. Indeed, 2014 marked the 6th year of a patent cliff in which a majority of U.S. blockbusters fell to generic competition. [1] Patent cliff notwithstanding, of the 43 global blockbusters on the market in 2012, 18…
FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity. [1] FDA explained that it has revised its interpretation of the term “drug” for the purpose of exclusivity eligibility from “drug product” to “drug substance”. Therefore, the 5-year NCE exclusivity determination will apply to…
The FDA Safety and Innovation Act (FDASIA) contains 140 pages of changes to the pharmaceutical industry, including a pronounced change to User Fees for Published Drugs and Biosimilar Products. These changes may have quite an impact on your strategic development plans, which addressing sooner rather than later can have a effect on your bottom line. …