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

When most people hear of, 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,

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. 

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,

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.

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.

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.”

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.

FDA Publishes Proposed Rule to Revise the Requirements for Combination and Co-Packaged Rx and OTC Products

In what appears to be an effort for FDA to harmonize their treatment of combination or co-packaged prescription or over-the-counter drug products, the Agency has published a 70 page Federal Register Notice addressing this issue.

The proposed rule notes that “[U]nder proposed § 300.53, two or more active ingredients may be combined in a fixed-combination or co-packaged drug or included as a combination in an OTC monograph when two requirements are met.”


Boy, FDA Can Move Fast When It Wants to!

The FDA announced the approval of Narcan (naloxone hydrochloride) Nasal Spray as an alternative emergency treatment for accidental opioid drug overdose.  Previously, naloxone hydrochloride, which reverses the effects of opioids very rapidly, was available only as an injection available in a syringe or auto-injector.

In a press release issued today (here),

Real Time Release Testing – Has its Time Come?

Generally, pharmaceutical manufacturing involves laboratory testing on product sampled at the end of the manufacturing process to assure the product quality as part of the product release.  However, traditional release testing is not the only acceptable approach used to assure the quality product prior to release.  On September 15, 2015, the European Commission published a revised draft Guidance,

 FDA Quality Metrics News

On 11/11/15, at the ISPE Annual Meeting in Philadelphia, Russ Wesdyk from the FDA Office of Surveillance spoke about quality metrics. Since the FDA Metrics Guidance is still in draft and the comment period is still open, he didn’t provide any specifics about the Guidance itself. Since its issuance, industry has been studying and commenting on each and every aspect of the Guidance,

Health Fraud – Dietary Supplements Warning Letters


A little more than a year ago, I gave a presentation on FDA hot topics.  One of the areas that was identified in my presentation was a potential for an increase in FDA enforcement efforts relative to dietary supplements, their claims, and the issues of new drug claims. I stumbled across a posting on the FDA webpage that gave examples of dietary supplement Warning Letters that were identified by FDA under the general classification of “Health Fraud”.