The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.
FDA issued an alert today telling healthcare professionals and patients not to use human and animal sterile drug product produced by a firm in Austin, Texas. After FDA inspection of the facility which found many objectionable conditions, the Agency recommended that the firm recall its products and cease production until the problems identified were corrected.
Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here). The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products. The document provides guidance for NDA holders (for new products or changes to existing products) and for ANDA applicants.
On January 25, 2016, this blog posted an article about some of the Guidance documents that FDA was planning to issue as new and or revised this coming year (here). In that blog post, it was noted that an update to that post would be coming-well here it is!
Some of the other notable documents we can all be looking for this year (with a little bit of editorializing) include,
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,
While 26-30 Inches of snow fell in the Washington DC corridor, the brunt of the storm has hit the FDA with offices being closed today while the dig out continues. For those of you who had GDUFA, PDUFA goal dates, or TADs scheduled for today, you may have to wait a day or two more for any actions to be issued and processed.
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.
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,
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 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.
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.”
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.
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.”
Thanks for reading our blog this year,
We write them with feeling and lots of cheer.
With GDUFA, QbD, and OPQ to understand,
Our team searched for news from throughout the regulated land.
The year 2105 went by so quick,
Picking the best blog topics was really the trick.
FDA approved the first genetically engineered fish which they have determined is safe for our food supply. The fish is engineered to grow faster, which will, of course, make it a more abundant food source. Who knew a fish could be approved through a new animal drug application (NADA)? Not me!