16
Oct

New FDA Guidance on PDUFA Fee Waiver, Reductions, and Exemptions Issues

It has been a while since the FDA updated its guidance on PDUFA fee waivers, etc., but the newly released Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products document provides much needed new information about the FDA’s fee program.  The Federal Register Notice (here) announcing the availability of the […]

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27
Sep
stack of one hundred dollars notes

New Fees Announced for Use of Priority-Review Vouchers

In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here).  Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for […]

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26
Sep
Human resources restructuring process illustrated on blackboard

CDER Office of New Drugs Reorganization and Impact on OPQ and Office of Translational Sciences Announced

CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here).  The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise.  The FDA says, “the changes increase the number of OND offices that oversee our review divisions from […]

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18
Sep
Petition Guidance Published Image

Revised 505(q) Petition Guidance Published

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that […]

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18
Sep
Extraneous Chromatographic Peaks Image

Extraneous Chromatographic Peaks – What’s a Lab to Do?

Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i].  This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations.  In 2016, […]

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11
Sep
Biologics

Generics Compete with Brands on Tiers and Appear to be Losing

Oh, the games that are played to keep market share are becoming more curious every day.  Just check out this article from Drug Topics penned by Louis Tharp and Craig Burton entitled Generics and Biosimilars Facing Formulary Difficulties (here). When Hatch-Waxman was passed, there were attacks on the bioequivalence of generic drugs, the quality of […]

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09
Sep
Scientific and Technical Assistance

Bioanalytical Laboratories:  What to Do with Variable Internal Standard Response?

For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.”  The Q&A guidance contains five questions, along with the Agency’s current thinking on […]

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27
Aug

FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovations Act

Contract Pharma published an article back in March briefing how the FDA will administer the transition of NDAs to BLAs. Facing the future transition of biological products from regulation as new drugs under the FFDCA to regulation as biologics under the PHSA in March of 2020, it is not too early to begin incorporating this […]

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