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 […]
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 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 […]
FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process. The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was […]
It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now. As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and […]
