Final Rule On Generic CBEs, EAR or a Variation Due April 2017

On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using Changes Being Effected (CBE) supplements (among other changes).  In response, on November 13, 2013, FDA issued notice of a proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”…

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When to Change Prescription Drug Labeling

When to Change Drug Labeling?

You don’t have to be a drug labeling consultant to realize that a case series of serious events in the literature, FDA safety alert, FDA labeling change notification letter, or other new safety information should prompt a review of drug product labeling (aka package insert). That is not what this paper is about. This paper…

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FDA Expedited Programs

FDA Expedited Programs for Drug Development and Review, Explained

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,…

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Do you know when to use the FDA Pre-Submission Program?

Do you know when to use the FDA Pre-Submission Program?

You just designed the greatest, cure-all class II medical device of all time! Terrific! Now what? Just go to the FDA website, follow the step-by-step procedures for submitting a “traditional” 510(k), submit, and cross your fingers, right? Not so fast! You have reached a critical point in terms of strategic development considerations. You could try…

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Generic Drug Consulting More Relevant Now Than Ever

Generic Safety Surveillance, Pharmacovigilance and Labeling Consulting Could Be More Relevant Now than Ever

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…

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Pharmaceutical Consultant on Adaptive Design Clinical Trials in 2016

Pharmaceutical Consultant on Adaptive Design Clinical Trials in 2016

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…

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Medical Device Consulting

Medical Device Consulting

PDG Has Provided Medical Device Consulting Services to Firms Around the World Since 1999 PDG offers one-stop-shopping to include 513(g) requests for information, pre-submission meetings (formerly pre-IDE meetings), IDE filing and Institutional Review Board (IRB) approvals, 510(k) and PMA submissions. Our expertise includes, clinical development in parallel with strategic regulatory planning and manufacturing and other…

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