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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05
Nov
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October 2020 Best Month in Last Eighteen for Generic Approvals

Unofficially, it appears that FY 2021 is being kicked off by the highest number of approval actions in the last eighteen months.  That’s right, it looks like the OGD will hit a total of at least ninety approval actions for October, which consist of at least seventy-seven full-approval actions and thirteen tentative-approval actions.  Why do […]

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04
Nov
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Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP inspections using interactive video or other types of interactive tools and techniques.  He noted that many companies have volunteered use of these types […]

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19
Oct

FDA/DOJ Gets Tough on Illegal Dietary Ingredient DMAA

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 […]

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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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17
Sep
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Official August 2020 Approvals and Receipts for ANDAs Reported

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 […]

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01
Sep
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EUA for Vaccine – Slippery Slope or a Shot in the Dark

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 […]

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24
Aug

After Some Missteps on EUAs, FDA’s Action on Convalescent Plasma Has the Science Behind It

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 […]

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