The use of novel excipients has potential to assist in the development of better final drug-product formulations for patients. However, drug-product manufacturers are hesitant to use novel excipients in product development because of the uncertainty of the expectations of the FDA and, ultimately, on the FDA’s acceptance of the new excipients in its development program. […]
We have all seen the FDA announcements about the use of Ivermectin, a drug approved to treat worms in humans and animals (and not to treat COVID), and you have likely seen the now infamous FDA tweet “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Yet people are continuing […]
In previous blogs (here, here, here, and here), we discussed abuse-deterrent formulations and the potential “creep” in applying this approach towards substances other than opioids. So far, we have not seen a big move in that direction, most likely because of the lack of any great success of currently approved abuse-deterrent formulations from actually preventing […]
Between a Rock and a Hard Place – Accelerated Approval for Alzheimer’s Drug Brings Cheers and Jeers!
Three FDA Advisory Committee members resigned over the FDA’s decision to grant accelerated approval to aducanumab for treating Alzheimer’s Disease. One member said, when he resigned, that “this is the worst decision the FDA has ever made.” I get it. When the entire committee voted against approval (full approval), the FDA kind of backdoored its […]
The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]
In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]
Wait a Minute, How Do We Go from Eliminating Drug Efficacy to Reduced Patent Terms… and Does Anyone Really Benefit?
I cringed while reading the opening two paragraphs of the article (here) written by Lawrence J. McQuillan in The Hill titled “How a reformed FDA can speed up delivery of lifesaving drugs”: The Biden administration favors a proposal to waive patent protections for the COVID-19 vaccines. But there are other ways to remove impediments to […]
There appears to be some concern about Janet Woodcock, MD being selected for the permanent FDA Commissioner job. Not sure why there is so much hype and concern. Most of the pressure being applied from the non-supporters focus on the opioid crisis; however, some critics are being quick to complain about the approval actions that […]
Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections. Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated […]
In a pre-publication notice today, FDA announced the FY 2021 fee for the use of a Tropical Disease Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher, or a Material Threat Medical Countermeasure Priority Review Voucher. That fee is $1,360,879 and remember that is to be paid on top of the $2,875,842 applications user fee […]