Is it a Drug, Device or Biologic? FDA Announces Changes to Request for Designation Program

In 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…

Latest Rx-to-OTC Switch: Prescription Veramyst® now OTC Flonase® Sensimist Allergy Relief

FDA 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…

Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie?

Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie? 6 MUST READ SCENARIOS

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.”…

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”…

When to Change Prescription Drug Labeling

When to Change Prescription Drug Labeling?

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…

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,…

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…