From the news stories on the price fixing suits, to the reported revelations about quality in the generic drug industry, or to the publication of a book titled “Bottle of Lies”, it has not been a good start to the news cycle for the generic drug industry this week. The report on price fixing was met with a response to 60 Minutes May 12,
Today, FDA finalized a guidance document (initially issued in draft in October 2017)that discusses how to best determine if your proposed product should be submitted as an ANDA (505(j)) or an NDA (505(b)(2)). We first blogged about this here. The selection of the type of application to submit has been a source of discussion ever since the Hatch-Waxman Act of 1984 created the 505(b)(2) process,
The FDA released a draft guidance today titled Submitting Documents Using Real-World Data and Real‑World Evidence to FDA for Drugs and Biologics (here) that describes how the Agency will receive Real World Data (RWD) and Real World Evidence (RWE) and the potential use of each. After reading the draft guidance, it seems to me that the industry is still far away from being able to rely on RWD and RWE for use in supporting initial application approval,
In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals. These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict clinical benefit.
FDA notes that it “identified 62 cases of complex sleep behaviors that resulted in serious injuries or death after taking insomnia medicines eszopiclone, zaleplon, or zolpidem reported in the FDA Adverse Event Reporting System (FAERS) database between December 16, 1992, and February 27, 2018, and four additional cases reported in the medical literature1-5 between December 16,
Well, for us old folks, change is always something that makes us queasy. The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks). There were some wrong turns and some dead links along the way,
Back in 2016, FDA indicated that it was planning to issue a guidance document to explain to firms how to extend expiration dating for doxycycline tablets and capsules held in national stockpiles (here) . Doxycycline is stored in national stockpiles for treatment of post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of an anthrax emergency.
This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive.
Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock
The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.
Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product. One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station).
On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>. Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products.
Required by Section 914 of the Food and Drug Administration Amendments Act of 2007, the annual report of the impact of 505(q) petitions and petitions for stay of action issued this last Thursday. This report discussed the number of such petition and describes any delays in approval that such petitions may have caused. The report covers FY 2017.
Day Two started with a recap of Day One (see post from yesterday here) by Dr. Nancy Snyderman.
Day Two kicked off with a session entitled Generics Help Patients, How Can Patients Help Generics. This centered on digital virtual prescribing, digital physician visits, and what’s going on in that space.
FDA notes on its User Fee web page (here) that the key date for acceptance of NDAs, BLAs, and ANDAs will be dictated by the first date that FDA could accept fees under the appropriation (after the shut down was over) which is January 28, 2019. The Agency gives the following advice as to how it will treat fee-paying applications and time periods for which fees must be paid (if not submitted at time of original submission of the application) (please see below):
- For ANDAs transmitted to FDA during the lapse period,
The Drug Price Competition and Patent Term Restoration Act of 1984 requires the FDA to publish a notice of all approved products and their marketing status. The FDA satisfies this requirement by publication of the drug products in the Orange Book; the FDA will publish information in the active section (if the product is currently being marketed) or the discontinued section (if it not being marketed for other than safety or efficacy reasons).