Generics

23
Jun

Well, May was Gray, as Official OGD Approval Metrics Reveal

Overnight, the FDA posted its official approval numbers for May 2021 and the picture is not great.  We reported in a previous blog post (here) unofficial totals of full-approval actions at forty-five and tentative‑approval actions at thirteen.  We missed by one on each as the official numbers revealed forty‑six full‑approval actions and twelve tentative-approval actions […]

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17
Jun

Halfway Through June 2021, Approval Actions Appear to Hit Sub-Par Numbers

We have reached the halfway mark of June and, as of the unofficial reporting through June 15th,OGD has issued just 24 full approval actions and 7 tentative approval actions.  Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the […]

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10
Jun

OGD Provides Updates to the April 2021 Statistical Report

The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]

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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The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements.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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20
May
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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