Bioequivalence

19
May

Petition Tests OGD Guidance on Use of Males and Females in BE Study

A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]

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18
May

FDA Releases New and Revised BE Product Specific Guidances

Today, the FDA released another batch of Product‑Specific Guidances (PSGs), outlining its current thinking on the bioequivalence (BE) testing requirements for generic products – twenty‑five new BE guidances and twenty‑one revised guidances.  The listing can be found here. The FDA has various goals regarding publication of these PSGs that are tied to getting information to […]

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31
Jan

FY 2022 GDUFA Science and Research Report – Impressive Findings and Conclusions

If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into.  The FY 2022 GDUFA Science and Research Report (here) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for […]

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17
Nov

FDA Provides Thanksgiving Gift of 49 New and Revised Product Specific Guidances (PSGs)

In its never-ending quest to provide timely guidance on bioequivalence requirements for generic versions of brand name products, today, the FDA published 29 new and 20 revised BE guidance recommendations in the pre-publication of Federal Register Notice (here) as well as on their website (here, hint: look for the newly added and revised links on […]

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08
Nov

GDUFA III Raises Hopes for Surprise PSG Issuance or Revision

GDUFA III Raises Hopes for Surprise PSG Issuance/Revision Explained at AAM’s GRx-Biosims Conference The product specific guidance (PSG) has been a big help to industry in outlining the requirements for establishing bioequivalence requirements for generic drug products.  OGD has issued over 2000 PSGs since the practice began.  While this has been a big boon to […]

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24
Oct

In a Very Topical Manner, FDA Introduces Guidance Documents to Get Under Your Skin

Last Friday, FDA issued four (4) guidance documents that establish the FDA’s current thinking on requirements for establishing sameness and bioequivalence of topical products.  They cover in vitro permeation testing, in vitro release studies, Q3 characterization studies, and studies required for corticosteroids of medium and high potency. While there have been many documents and discussions […]

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02
Aug

More PSGs Added and Revised

Today in a prepublication Federal Register notice, (due to be published tomorrow), the FDA announced the addition of 29 new and 19 revised product specific guidance (PSG) documents.  The Agency acknowledges that, “as part of FDA’s commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference […]

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08
Mar

Age and Sex in ANDA Bioequivalence Studies – Discrimination Could Cause Problems!

On February 24, 2022, the Small Business and Industry Assistance (SBIA) group at the FDA hosted a webinar titled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (you can view the recording here).  The goal was to describe the eight major changes to the August 2021 revision to the guidance Bioequivalence Studies […]

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