Today, December 17, 2020, the Vaccine and Related Biological Products Advisory Committee meeting discussed the Moderna vaccine. That vaccine is an mRNA vaccine, much the same as the Pfizer-BioNtech vaccine. To remind you, the mRNA vaccine: Does not replicate Does not enter or integrate into DNA And the Moderna vaccine does not contain any preservatives […]
While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I. Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]
Oh, what a year it has been! Political turmoil topped only by the devastating novel coronavirus. With a vaccine EUA and vaccine on the way, perhaps 2021 will see an attenuation of the Covid-19 pandemic and our businesses and the world will start to open up again. Small businesses have been devastated, the world has […]
November OGD ANDA approval actions totaled seventy-six, down from the ninety-three seen in October. The seventy-six approval actions consist of fifty-five full-approval actions and twenty-one tentative‑approval (TA) actions. Twenty-one TA actions is relatively high and came in second over the last FY with April 2020 generating twenty-two TA actions. In the beginning of FY 2019, […]
Today was the FDA vaccine advisory committee meeting to provide feedback to the FDA regarding the Pfizer-BioNtech COVID-19 vaccine. I don’t think anyone will be surprised by the outcome, especially since the pre-meeting package written by the FDA was extremely favorable regarding the safety profile and the very high efficacy rates seen in the study. […]
Based on the FDA advanced posting of material regarding the advisory committee meeting tomorrow to consider an EUA for the Pfizer vaccine, it appears that there should be clear sailing. From the materials that I was able to review, there were very few serious adverse reactions, 95% efficacy rate, and low episodes of severe disease […]
In May of 2014, the FDA issued a draft guidance entitled Best Practices in Developing Proprietary Names for Drugs. This draft guidance contained recommendations for the selection of proprietary names for both prescription (Rx) and over-the-counter (OTC) medications. In the 6-and-a-half-year interval that has passed since the issuance of this guidance, the FDA has initiated […]
The unofficial November totals for approval actions and tentative-approval actions for month two of FY 2021 dropped from a total of ninety-three to seventy-two. The seventy-two can be broken down into fifty-five full-approval actions and seventeen tentative-approval actions. As with every month, the totals may change a bit when the OGD reports its official numbers sometime […]
I read an Axios report this morning (here) written by Jonathan Swan, indicating that FDA commissioner Stephen Hahn has been summoned to the West Wing by White House Chief of Staff Mark Meadows to explain “why he hasn’t moved faster to approve the Pfizer coronavirus vaccine“. This type of pressure has no place in science. […]
I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market. Firms need to […]
