Issued on August 8, 2016, regulatory impact includes the following: FDA issued the original Deciding When to Submit a 510(k) for a Change to an Existing 53 Device (K97-1) on January 10, 1997 to provide guidance on this regulatory language This draft guidance preserves the basic format and content of the original, with updates to…
DetailsIn case you need a regulatory refresher, the Request for Designation is the formal process to determine which Center will conduct premarket review and regulate a combination product (See Guidance for Industry Office of Combination Products April 2011: How to Write a Request for Designation). Recently, FDA announced through FDAVoice that changes to the program…
DetailsFDA recently approved another Rx-to-OTC switch. Formerly available by prescription only, Veramyst® will now be known for the purpose of OTC marketing as Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray). Sensimist™ (NDA 022051/S-013) is approved to treat symptoms associated with seasonal and perennial allergies. Read the full story here. The path to the…
DetailsFDA recently announced on FDAVoice that they plan to facilitate ways to encourage industry to submit an NDA for an Rx-to-OTC switch. The announcement directly addresses prescription naloxone, indicated for treatment of opioid overdose. This unusual step is consistent with FDA’s opioid action plan and is aimed at making the drug more widely available. To…
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As a prescription and OTC pharmaceutical consultant, I am repeatedly amazed by the successes resulting from the simplest of drug & device development ideas. While it may be legend, it is said that Charles H. Duell, Commissioner of the US Patent Office in 1899 coined the phrase “everything that can be invented has been invented.”…
DetailsFirst 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 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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