New Drugs

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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12
Nov

Mission Critical Inspections, What About Me?  What’s a Body to Do?

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 […]

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21
Sep

FDA’s “Be Safe” Program Provides Advice on Online Pharmacies

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 […]

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10
Jul
Wolf howling to the moon

Domestic Priority Inspections to Restart on July 20 – With Conditions

FDA announced a target date for the resumption of prioritized domestic facility inspections beginning on July 20, 2020.  The Full FDA announcement can be found here. FDA points out that they will be closely watching the trajectory of COVID-19 cases by area, as well as other logistical factors (i.e., public transportation) and will make decisions […]

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29
Jun
Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2.  Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

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15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”.  The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]

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