New Drugs

06
Dec

New Dissolution Method for Long-Acting Injectable Suspensions May Provide Better Data

FDA and industry have long wrestled with appropriate dissolution methodology for injectable suspension products. Investigations into the relevance of the dissolution methods utilized has shown wide variation in in vivo results despite consistent in vitro performance. As FDA notes in a recent article (here) on the new potential improved method developed to address “gaps between […]

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07
Sep
Novel Photo

Pilot Program for Novel Excipients Announced

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. […]

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28
Jun

Benzodiazepines in the Crosshairs?

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 […]

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11
Jun
Sockeye Salmon Jumping Up Falls

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 […]

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03
Jun

FDA Publishes Four Guidances on Supply Chain Security Issues

The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements.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 […]

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27
May

Is This the Beginning of Withdrawal of the Withdrawal of the Unapproved Drug Initiative?

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 […]

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24
May

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 […]

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25
Feb

Damned If You Do and Damned If You Don’t – Thinking About a New Permanent Commissioner

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 […]

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