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 (September 16th) on the Product-Specific Guidances for Generic Drug Development (here).
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,
For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.” The Q&A guidance contains five questions, along with the Agency’s current thinking on each topic.
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).
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 OGD will beat the last two fairly slow months that had total approval actions of 62 (45 full and 17 tentative),
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!
It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments. There should be a controlled, comprehensive list of the instrumentation within the laboratory,
When it comes to ice cream and desserts, I must admit the more the better in my opinion. The same, however, doesn’t hold true for laboratory testing and the resultant data. All testing performed and data generated must be accountable to ensure the integrity of the data. Performing extra testing, even if with all good intentions,
In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling. The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.
As a reminder, the FDA has not regulated child-resistant packaging since 1973,
Take action now to assure that your facility information, drug listing information, and manufacturing sites are correct and that no changes have been made to any of these items or others that are listed in the FR notice due to publish on Wednesday (pre-publication notice here).
The Notice indicates registrant’s responsibilities as follows:
Each registrant must list all drugs it manufactures for commercial distribution within 3 days of initial registration (21 CFR 207.45).
We hit the nail on the head in our August 2 post (here) as we reported sixty-one full-approval actions and fourteen tentative-approval actions for July 2019. This was the first time in a while that the official numbers did not change after our review of the unofficial counts from the FDA’s All Approvals page.
The Office of Generic Drugs (OGD) updated the June statistics late yesterday (here). Here are some of the highlights!
The refuse-to-receive (RTR) actions were low again with just five RTRs issued in June and all were for standard applications. The total for the year, based on the last nine months (forty-two so far),
In a series of four Federal Register Notices issued today, the FDA announced the fee structures for the last four UFAs for Fiscal Year 2020.
It is no surprise that the PDUFA fees are the highest overall in total, with well over $1 billion in potential collections. The fees for each of the programs are presented in the tables below,