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What It Is May Not Be What It Is!

In a Federal Register notice (here) that will publish on Monday, August 30th, the FDA announced that it “is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc.”  Breckenridge waived its opportunity for hearing on the proposed withdrawal. What makes this instance so […]

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Blood donation hand. Nurse hands

Official OGD June Approvals, Receipts, and CRL Numbers are In and I Just Scratch My Head

Well, with the only reported number that is up this month being for the receipt of new ANDAs (seventy‑six, the third highest number of new ANDA submissions in a month thus far this FY), I think we have some head‑scratching to do.  Should the current rate of new ANDA submissions continue in the fourth quarter, […]

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Businessman Walking Into The City

FDA Field Alert Reports (FARs) far from Clear – Maybe This Will Help

The FDA issued its final guidance on Field Alert Reports (FARs) today (here).  This guidance finalizes the draft guidance of the same title issued on July 19, 2018. FARs have been the subject of much misunderstanding and interpretation regarding when, what, how, and where reports should be sent.  I can’t tell you how many times […]

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Digital or electronic thermometer with high temperature 98,6 Fahrenheit in doctors hand. Doctor or nurse in protective PPE suit, face mask, safety googles and rubber gloves demonstrates temperature caused by covid 19, coronavirus or Sars-Cov-2

Domestic Inspections Back to Normal – Mission Critical Still for Foreign In-person Reviews

With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work?  Question number 2 is then what do we anticipate seeing from these new domestic inspections? With it being over a year+ (March 2020) since […]

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Real World Evidence/ Real World Data Marks Approval of New Use of Existing Product for Transplants

We have heard a lot about the use of real world evidence (RWE) and real world data (RWD) lately in the context of potential approval of new uses of approved drugs.  Well, on July 16, 2021, FDA “approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of […]

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