First approved in 1996, FDA recently approved a supplemental NDA (20380/S-010) for Differin® Gel (adapalene), 0.1% to be marketed as a nonprescription product in 2, 15, and 45 gram containers. In the approval letter, FDA noted that “usage and exposure were key review issues in our evaluation of the potential risks of nonprescription marketing. Research…
DetailsAccording to FDA, Consumers should “Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” Click here for the full story or here to learn more about OTC drug development.
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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Medical device consultants on another lesser known, yet beneficial FDA program It’s time to submit another run of the mill traditional 510(k) for your medical device = same old fee, same old timeframe. You are just going to submit your 510(k) to the FDA per usual and wait 90 days for feedback, or hopefully that…
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You don’t have to be a prescription 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…
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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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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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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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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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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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