Generics

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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03
May

Is the New Proposed Legislation (S-1462) Regarding ANDA Suitability Petitions as Good as it Sounds?

The ANDA suitability petition process has been languishing for years.  Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition.  Today, I read […]

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29
Apr

Day Two of the Generic Drug Forum – Morning Sessions

Starting at the crack of dawn for us west coasters, today’s meeting kicked off with three presentations on application issues: mid-cycle meeting overview; information to include in cover letters; and application communications – quality perspectives.  Lots of information was presented and highlights are discussed below. Mid-cycle reviews are reserved for complex generics and may also […]

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29
Apr

Day Two Generic Drug Forum Afternoon Sessions

The afternoon started out with a discussion of Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms.  The presentation provided an introduction to the understanding of the purpose of biopharmaceutics risk assessment and a discussion of how to perform the assessment which focused on understanding the role of in vitro dissolution […]

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