Two executives of a dietary ingredient company were sentenced to sixty months and twenty-four months in prison, respectively, for their part in the distribution of two products, Jack3d and OxyElite Pro, touted as workout weight-loss supplements, both containing DMAA, according to a Department of Justice release (here). The FDA had warned consumers about the dangers […]
The news is rife with stories about counterfeit drugs, illegal operating on-line pharmacies, on-line pharmacies dispensing sub- or super-potent medicines, some act as virtual opioid pill mills, but the FDA has launched a campaign to help consumers navigate the online pharmacy morass. Released this morning the FDA’s web page (here) asks in its opening line […]
The Office of Generic Drugs (OGD) reported some of its official statistics for August today. As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]
Although we were caught off guard by a slightly early update to the July metrics which preceded Official August approval and receipt numbers, we are happy to present them to you at this time. OGD issued 4 refuse-to-receive (RTR) actions and all four were for standard ANDAs. The Agency acknowledged (filed or received, whatever you […]
The FDA has backed away and revoked a number of Emergency Use Authorizations (EUAs) that it had issued in the past, including those for hydroxychloroquine and a multitude of less-than-accurate COVID‑19 tests. By all accounts, there is a degree of trepidation in the scientific community that many of the Agency’s decisions regarding EUAs are being […]
Clearly, the FDA has acted too early on Emergency Use Authorizations (EUAs) for a few COVID-19 tests and products. The flurry of revocations of EUAs for tests that were deemed not reliable have cause a sputter in the onset of testing ramp up. Another specific example was the FDA’s EUA for hydroxychloroquine, which left many […]
There has been a lot of discussion about the need to retain up to five times the amount of test and reference drug product to perform release testing as reserve samples for products used in in vivo or in vitro bioavailability (BA) or bioequivalence (BE) testing for NDA or ANDAs products. The requirements were at […]
OGD reported 69 full approval actions, which we hit on the head, (three of the full approvals were for first time generic approvals) and 13 tentative approval actions (we reported only 9, as that was all that was found on the FDA’s All Approvals site at the time) for a total of 82 approval actions […]
FDA finalized its guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018. The FR Notice announcing the availability of the guidance (here) indicates […]
How has COVID 19 changed your organization? Do you have fewer or newer employees? Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving? Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA? […]
