Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i]. This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations. In 2016, […]
The Office of Generic Drugs is publishing thirty-one new and fifteen revised bioequivalence guidances according to the pre-publication notice that appeared in the Federal Register today (here). The official FR notice is scheduled to publish on September 17, 2019, but a quick check reveals that the new and revised guidance documents are already available today […]
OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here). However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative […]
Oh, the games that are played to keep market share are becoming more curious every day. Just check out this article from Drug Topics penned by Louis Tharp and Craig Burton entitled Generics and Biosimilars Facing Formulary Difficulties (here). When Hatch-Waxman was passed, there were attacks on the bioequivalence of generic drugs, the quality of […]
According to all of the published approval data on the FDA All Approvals List (here) and the Drugs@FDA: FDA Approved Drug Products (here), the OGD has taken full-approval action on fifty-nine ANDAs and tentative approval action on twelve ANDAs for a total of seventy approval actions in August. But wait – there is something amiss! […]
The Office of Generic Drugs provided an update late last night to its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here). Not too many surprises, but there are a couple of numbers that are of interest. Let’s start with refuse-to-receive (RTR) actions. There were only two RTR actions in July (both […]
Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this […]
This morning after reading an article in the Pink Sheet entitled US FDA Urged To Stop Slowing Approvals By Seeking Metals Data From Suppliers written by Joanne S. Eglovitch, my mind harkened back to the early 2018 slowdown (and almost stop) in ANDA approvals based on the elemental impurities issue (see earlier post (here). The […]
I don’t know about you but has this year flown by or what? Summer will be over on Labor Day and there will be only one month left in FY 2019. OGD approval actions thru reporting on August 22 show OGD with 53 full approval actions and 11 tentative approval actions. Thus, it looks like […]
As I read the article “Prescription-drug policy: Don’t throw the bed out with bedpan”, written by Jim Waters in the Bluegrass Institute (here) about the “Pay-for-Delay issue, I harkened back to a position I took in a very old FTC law suit (that FTC won) and thought – well, someone else gets it! While I […]
