Cloud_computing

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products.  What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS).  Running applications in the cloud is a relatively new concept for many industries,

Cloud_computing

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products.  What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS).  Running applications in the cloud is a relatively new concept for many industries,

FDA building

CDER Outlines Proposed Guidance Documents it Proposes to Issue in 2016

On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016.  This yearly wish list is always a highlight of the beginning of every calendar year.  The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise.  This year the guidance agenda has 15 different categories and lists 102 different guidance documents it hopes to issue this year. 

Mortar pharmacy

Compounded Hormone Products Are a Big Business – Medical Groups Raise Concerns

According to a recent article in Medscape Medical News (here), the use of compounded hormone therapy to treat symptoms of menopause is a big business and accounts for a significant percentage of some compounding pharmacies income.  The article provides an estimate of $1.3 -1.6 billion annually.

With the flurry of FDA enforcement actions on pharmacy compounders,

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If Wall Street and the Regulators Speak – Then Something is Likely to Happen!

I recently read a very interesting article about some big vitamin companies and their stock performance. I think that it deserves some attention because, when people outside of the Food and Drug Community start writing about potential problems, and when those problems translate into increased FDA enforcement actions, then Congress takes note and then (all of a sudden) laws get rewritten and regulations get passed and, the next thing you know, a segment of the industry is changed forever – or at least until the next time the government changes its mind.

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Court Challenge Forces Firm to Change Color of its Generic Nexium Capsule

As previously reported (here), Dr. Reddy’s generic of Nexium was too close to that of the innovator’s “Purple Pill”. Apparently, the firm has changed the color of its capsule and reintroduced the product. But, this does reinforce that fact that generic companies, despite the Office of Generic Drugs’ (OGD) input, desire to have the generics look more like their brand name counterparts.

Scales of justice and gavel on desk with dark background that allows for copyspace.

FDA Takes Injunctive Action Against Pharmacy Compounding Outsourcing Facility

FDA has given new notice to registered pharmacy outsourcing facilities that it is prepared to take aggressive enforcement action against serious violators. In one of its first major enforcement actions of 2016, a Consent Decree of Permanent Injunction was entered on January 8th against Downing Labs (formerly NuVision), a Dallas, Texas outsourcing facility manufacturing both non-sterile drug products and injectable drugs.

Some fibres examples in a every day food

Should the Term “Natural” Be Allowed on GMO Foods? – Well, FDA Asked and the Public Answered!

Not too often do you see the public gather around an idea so emphatically and in such numbers.  This struck me when I was looking through the public comments on Docket FDA-2014-N-1207.  To date, there are about 3000 comments posted; all are available on regulations.gov.

The issue of the docket relates to the use of the word “natural” in the labeling of human food products. 

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Dietary Supplement Actions Continue

Recently, FDA took administrative action by detaining at the border a product containing kratom, a plant material that may have the potential for abuse and potential serious health consequences. Then the Department of Justice filed a complaint in US District Court on behalf of the FDA “alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements containing kratom are adulterated under the FD&C Act.”

Scales of justice and gavel on desk with dark background that allows for copyspace.

DOJ to Continue Tightening the Screws in 2016

The Department of Justice (DOJ) and its federal partners are being very vocal about turning up the heat on compounders and dietary supplement manufacturers and marketers in 2016 and beyond. 2016 is guaranteed to be a record year for enforcement actions against manufacturers of these products that are not in compliance with the regulatory framework governing their manufacture and distribution.

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