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 […]
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 […]
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 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 […]
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 […]
