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 […]
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 […]
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 […]
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), should be […]
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 […]
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 […]
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. The product is a […]
In a Federal Register Notice to be published tomorrow (here), the FDA announced GDUFA User Fees that will be in effect for Fiscal Year 2020, which begins on October 1, 2019 and continues through September 30, 2020. There is some good news and some bad news. Here are the application, DMF, and facility fees for FY […]
According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019. However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019. This got my mind working to try to figure out why the 17-day (June 30 fell […]
