The labeling for approved antifungal and antimicrobial prescription drug products contains certain language regarding the susceptibility test interpretive criteria (STIC) and associated test methods and quality control standards, with associated references for antimicrobial drugs for the specific compound. Many approved drug products have been around for a long time and the information regarding the STIC in their labels are outdated.
In a recent guidance issued by FDA entitled Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements (here), the Agency provides current guidance on the various aspects of proprietary and established names in advertising.
The document clarifies the relationship between the size (and not type size) of the proprietary name and established name in running text in advertisements and promotional material where the established name must be at least one-half the actual size of the proprietary name.
FDA posted Donald Ashley’s, Director of the Office of Compliance (OC), presentation (here) at the FDLI Enforcement, Litigation, and Compliance Conference presented December 6, 2017. Mr. Ashley provided some interesting enforcement information, some of which is presented here.
The FDA’s Biomedical Monitoring (BIMO) program warning letters issued over the last 4 fiscal years is captured in the slide below.
For the battle to fight opioid addiction and the so-called opioid use disorder (OUD), the FDA has given patients and practitioners another tool. This once-a-month injection is indicated for OUD for patients on a stable dose of buprenorphine for at least 7 days. Previous treatments with this drug required daily doses of orally administered products like films or tablets,
Well, here we are, just before Thanksgiving again. It seems like just last week we were getting ready for last year’s shindig. We certainly have a lot to be thankful for this year and on top of the list is a clean bill of health after a horrible 2016 for my family. Second is the fact that we are all still here and that you,
Well, in the dietary supplement battle for the erectile dysfunction (ED) market, it seems that FDA continues to find supplements that contain undeclared drugs. In a public notification today, FDA advised consumers not to use yet another product for ED (see here). As reported previously, it seems that FDA issues a few notices a month for products claimed to be dietary supplements,
The answer to the question of whether current cleaning validation limits generally in use in the industry (1/1000th of the minimum therapeutic dose of a drug product or 10 ppm) should be revised in favor of a Health Based Exposure Limit (HBEL) based limit was one of the major discussions at a “Workshop on the Generation and use of Health-Based Exposure Limits” held on 20-21st June 2017 at the European Medicines Agency.
As stated in the FDA November 2016 draft Guidance, Submission of Quality Metrics Data – Guidance for Industry (here), one of the Quality Metrics that the FDA intends to monitor is the Invalidated Out-of-Specification (OOS) Rate (IOOSR). The IOOSR quality metric is the number of OOS test results for lot release and long-term stability invalidated by the covered establishment due to an aberration of the measurement process divided by the total number of lot release and long-term stability OOS test results.
From August 2016 to October 2017, FDA has issued 63 Warning Letters (an average of 4 per month) and has orchestrated 4 Injunctions and multiple prosecutions against Compounding Pharmacies and their Principals. Most of the Warning Letters deal with citations for insanitary conditions for compounding and for lack of sterility assurance for compounded preparations.
It is certain that FDA is continuing to apply pressure on this industry with no letup in sight.
My previous guest blog post, “Taking Care of Our Neighbors” (here), was focused on improving the health of uninsured, low income Americans, and the Dispensary of Hope’s incredible collaborative network. Today, my mind is on the need for a change in our economic perspective as it relates to improving the health of our uninsured friends,
There has been a ton of news in the pharmaceutical world this week so I thought I would diverge from my usual posts to provide some brief sound bites of things that caught my interest and will hopefully catch yours.
First off, remember the New England Compounding Center (NECC) and the meningitis outbreak of 2012?
It appears that FDA may be close to issuing a less onerous version of its July 2014 Draft Interim GMP Guidance for Section 503B Drug Compounding Outsourcing Facilities. Reuters reported last week that in an interview with FDA Commissioner Scott Gottlieb, the Commissioner stated that to encourage more firms to register as compounding outsourcing facilities (to date,
The CDER website provides the following information relative to the new outsourcing compounders fees for FY 2018.
Compounders Outsourcing Fees FY 2018
* To qualify revenue must be less than $1,000,000 for all sites and affiliates
The Notice states that “FY 2018 registration period for outsourcing facilities starts on October 1,
In a Federal Register (FR) notice published today (here), the FDA announced that the base amount for the prescription drug user fee (PDUFA) program for new drugs would be $878,590,000, plus another $22,415,658 from something called the “capacity planning adjustment”, which is based on the elements the Agency is using to calculate costs (see list below) ,
The ISPE has issued a GAMP: Records and Data Integrity guide which provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate and available throughout their lifecycle. A critical component of the data lifecycle is Data Review.
Data review should be based upon a thorough process which is defined within the procedure.