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  This guidance finalizes the draft guidance of the same title issued on July 19, 2018.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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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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Old wagon in the desert

While Not Entirely New – Guidance Places Stamp of Approval on Some Synthetic Peptides Where the RLD is of rDNA Origin

For the last 5 or so years, the FDA has told applicants that they could likely submit an ANDA for a synthetic peptide product (40 amino acid chains or fewer) when the reference listed drug (RLD) was of rDNA origin but the guidance on which products, how, and what would be required was often sketchy.  […]

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