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),
I railed about drug importation as a way to lower drug costs in a previous post (here) for numerous reasons. For instance, how can you protect against counterfeit drugs, how do you know how the products are stored and where they have been in the supply chain, and how are you assured of drug product quality?
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,
In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020. The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020.
The medical device fees are provided in the charts below,
California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum). This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and it focused on the draft International Conference on Harmonization (ICH) Q12 guideline (here) which addresses the technical and regulatory aspects of reporting post-approval changes to the regulatory bodies.
In announcing the July 24th approval of Baqsimi (glucagon powder for nasal administration) (here) FDA notes that it is the first form of glucagon that can be administered without injection. The product is to be used by a caregiver or we assume someone on the street if the patient is unconscious.
Like many drugs that undergo clinical trials (even larger trials), rare adverse events may not become apparent until well after the drug is in wider use after approval. In addition, as a condition of approval, the FDA often requires a post-approval commitment to further study the drug. Such is the case as described in the updated Safety Communication released today by the Agency as FDA announced it approved “a Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz,