The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period. On its current list (here), […]
With seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions. The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions. Unless the end of the month picks up, we could see the slowest month for […]
“Complete” seems like a simple unambiguous word. So why do so many firms struggle with complying with the following two predicate rules of cGMP compliance? 21 CFR 211.188 Batch production and control records (here) “Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the […]
With the end of the first quarter of FY 2020 approaching, the official numbers from FDA show a big jump from the meager number of new ANDA submissions the first two months of this FY with the December receipts hitting a 2 year high at 149. Of course, this is likely due to getting the […]
In a January 14, 2020 Drug Safety Communication (here), FDA discusses an alert to patients taking the weight loss drugs Belviq or Belviq XR (lorcaserin) of a potential increase in the risk of cancer. The NDA drug products were approved on July 27, 2012 (immediate-release) and July 15, 2016 (extended-release version), respectively. The Agency notes […]
While I do happen to reside in California, I won’t take any blame for the Governor’s idea for California to become a private-label distributor of generic drugs. This idea leaves me scratching my head and may have something to do with someone smoking some really potent wacky weed. Sorry that I don’t know the specific […]
OGD reported the approval of 108 first time generic approvals in CY 2019. This is the highest total in at least 4 years, with previous totals of 99 for 2018, 80 for 2017, and 73 for 2016. There are many reasons for variations in the number of first approvals, some of which relate to the […]
In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports. The notice announces the opportunity for a hearing for any of the applicants. Many of the ANDAs are old applications, with some from […]
Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs. There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]
The World Health Organization (WHO) issued a draft guidance document titled “Guideline on Data Integrity” (October 2019) and within the document there is the statement: “Quality risk management (QRM), control strategies and sound scientific principles are required to mitigate such (Data Integrity) risks” and then further it states: “application of QRM with identification of all […]
