THE LATEST FROM FOCAL POINT RESEARCH

FDA Approves Pill that Tracks Ingestion

FDA Approves Pill that Tracks Ingestion

Many people are familiar with that feeling of uncertainty when you can’t remember if you took your medication or not. Sometimes, missing a pill isn’t such a big deal. Other times, it can have serious consequences. To deal with these issues, Proteus Digital Health and Otsuka Pharmaceutical have obtained FDA approval for the world’s first digital pill that can be tracked. Named Abilify MyCite, the pill contains aripiprazole for the treatment of adults with schizophrenia, acute manic and mixed episodes, bipolar I disorder, and major depressive disorder, as well as a tiny embedded sensor. The sensor is activated by stomach juices after the pill is swallowed and dissolved, allowing it to transmit data to a patch worn by the patient, and from there to a smart phone or tablet to notify the patients caretakers or doctor that the pill has been ingested. The sensor is then passed through the gastral intestinal (GI) system naturally. Despite the benefits offered by this new technology, it should be noted that Abilify MyCite’s labeling states that it should not be used for “real-time” ingestion tracking or during an emergency because detection may be delayed. Some patients may also experience irritation [...]

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FDA Releases Draft Guidance on GDUFA II User Fee Structure

FDA Releases Draft Guidance on GDUFA II User Fee Structure

Following the reauthorization of the Generic Drug User Fee Amendments (GDUFA II), the FDA has released Draft Guidance outlining the new fee structure and types of applicable fees. The guidance outlines how payment of fees can be made, the consequences of non-payment of fees, and which parties may make fee payments. Information on fee refunds and appeals is also included in the guidance.

Background

The Generic Drug User Fee Amendments of 2012 authorized the FDA to collect user fees for a period of 5 years from parties that submit certain Abbreviated New Drug Applications (ANDAs) for review, or that are referenced in certain ANDAs. These fees help fund and expedite the review and approval process of drugs

Changes to the GDUFA Structure

GDUFA II authorizes the FDA to collect several types of fees for the 2018-2022 period:
  1. Backlog Fees
  2. Drug Master File (DMF) Fees
  3. ANDA Filing Fees
  4. Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) Facility Fees
  5. Generic Drug Applicant Program Fees (GDUFA Program Fees)
GDUFA II replaces the previous structure’s Prior Approval Supplement (PSA) Fees with the Generic Drug Applicant Program Fees. Facilities that manufacture both APIs and FDFs will only incur FDF fees. Facilities that are only referenced in [...]
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Innovation Is More Than Just Tech

Innovation Is More Than Just Tech

I constantly scan the business news looking for innovation I can relate to. Sadly it seems that if you are not writing code for a new app, you’re not innovating. Okay maybe there’s an exception if you are splicing a mouse gene into an apricot. But the news just doesn’t pick up on the vast variety of dynamic industries that are generating billions of dollars and all the innovations behind them. Let’s start with cosmetics. It’s an industry often seen as lightweight, not doing anything particularly important. But it has proven to be an industry with an endless appetite for “new”. Sometimes it’s new branding. Sometimes it’s a new concept. But often now it’s new technology. The amount of innovation going on in the cosmetics industry is mind-boggling. We have better products than we’ve ever had. We now have technology that can screen out the sun’s harmful rays better, that can moisturize your skin better, and even technologies now that can repair damaged skin. It has become almost impossible to keep up on the constant innovations in this industry. Successful start-up companies are being gobbled up by multinationals like never before. We are hearing they are going for 10 times revenue, [...]

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Focal Point Research Inc. Lecture Series is now Live!

Focal Point Research Inc. Lecture Series is now Live!

Focal Point Research is proud to announce the launch of its new lecture series. We have developed these lectures to help entrepreneurs, product developers, marketers and others involved with the launch of new products. These lectures will be of most use to those working in consumer products, cosmetics and beauty products, OTC drugs, medical devices and nutritional supplements, but at least some of our lectures will have application to anyone interested in bringing new products to market. We developed these lectures after decades of helping countless individuals and corporations develop and launch their products. This process is difficult, expensive and often frustrating. However it can be incredibly rewarding and profitable if done properly. Sadly, the road to a new product can be filled with detours, roadblocks and a few disasters. Our aim is to help minimize the pain and maximize the gain. The lectures will be delivered by our President and CEO Rob Fichtner who is a career scientist, product developer and much sought after speaker. Rob spent almost 20 years at Procter & Gamble where he served as a research scientist, process engineer and R&D Manager, working in both Canada and the United States. Since leaving P&G, Rob has been a [...]

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NAFTA Won’t Matter if we make Lousy Products

NAFTA Won’t Matter if we make Lousy Products

There is a whole lot of panic in North America surrounding the reopening of the historic trade agreement NAFTA between Canada, the United States and Mexico. While the discussions swirl around tariffs and protectionism, completely absent from the NAFTA discussion is the subject of product quality. Product quality as in the design of a product, and its consistent quality during manufacturing. If we make lousy products, nobody will buy them. And evidence has it that we have a long way to go. We are involved with hundreds of products being manufactured around the world, and at times I am appalled by product quality coming of North America. Admittedly poor quality products can come from anywhere, but North America is our backyard so we need to talk about it. Not to say we can’t and don’t make some excellent products. But in the sectors we work in, far too often my phone rings and I hear about high rates of defects, cost overruns and enormous delays. It’s inexcusable and life-threatening for what remains of our manufacturing base. The number of countries competing for product design and manufacturing around the world is staggering. I sure didn’t see it coming but South Korea has [...]

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