FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018. This is quite an ambitious agenda! This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see if some of your interests will be met or augmented by some additional Agency guidance.
Here it is, 11 days into January 2018, and so far this month (at least at the last check this morning) OGD had approved only two ANDAs. Could it be that they pushed so many out in the first quarter of FY 2018 that there were none left to cross the finish line in early January,
The proverbial title of a 1962 hit song by Petula Clark is something that piqued my curiosity today. And yes, I am that old (I was 13 when that song came out and I loved to play with my pet dinosaur). Anyway, I digress! The reason I bring up “Never on Sunday” is, because, as I flip through the FDA’s All Approvals list,
To reiterate our post of December 27, 2017 (here), please start working on your one time report on the marketing status of your products listed in the Orange Book. The deadline is approaching and FDA even republished its advice to industry (here) again today!
Don’t be left without a retort – be sure to submit your report!
After the glow of the holiday season, and after the big bowl games and national football championship, you better get the team prepared to file your one-time report of the marketing status of every one of your NDA and ANDA products.
FDARA requires every firm to submit the one time written report telling FDA if:
- the NDA or ANDA holder’s drug(s) in the active section of the Orange Book are available for sale;
Here we are, at the end of another busy year. As a matter of fact, this blog is celebrating its 5th year of missives that we hope have provided you a different perspective into the world of FDA, along with some laughs along the way. It has been a pleasure sharing all the ups and downs,
Those homeopathic drug products for which no determination that the product is a new drug may be marketed under the Federal Food Drug and Cosmetic Act. However, given the current burgeoning homeopathic market, the FDA held a public hearing on March 27, 2015 to seek comments on its current regulatory framework for such products. “As a result of the Agency’s evaluation,
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.