Generics

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The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements.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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19
May

New Complex Generics PSGs Planned as Well as Some Revisions

Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development.  Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.”  This comes after several public […]

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17
May

OGD Posts Official Approval Action for April along with CRLs and ANDA Submissions

Well, our unofficial projections got the full approval actions right (at 55) but we missed one tentative approval action that was posted late (we reported 16) (here) but the official total reported here actually tallied 17 for a total of 72 approval actions for April 2021. 11 of the 55 full approvals were for first-time […]

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