Generics

06
Dec

November Is “Unofficially” in the Books – OGD Approval Numbers Await Official Publication

Well, here we are at the conclusion of the second month of FY 2023 and we can still only report unofficial approval numbers.  At least we know the reason why (see previous post here), but it’s very important to continue to track these metrics as approvals are the lifeblood of the generic pharmaceutical industry. We […]

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29
Nov

Where Have All the Official Stats Gone, Long Time Passing!

The FDA is usually pretty consistent with the timing of their publication of official OGD metrics, especially when it comes to the publication of the Generic Drugs Program Activities Report – Monthly Performance.  The first month of official stats has not yet been available and it is almost December. I was curious about the delay, […]

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15
Nov

OGD Extolls Review Enhancement at GRx+Biosims Meeting

At the AAM GRx+Biosims meeting last week in North Bethesda, Maryland, Ted Sherwood, Director of the Office of Regulatory Operations, Office of Generic Drugs, indicated that the negotiations for GDUFA III had led to a number of program enhancements in the generic drug review and approval processes.  He outlined a number of these changes from GDUFA II […]

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14
Nov
CHANGES AHEAD: Roadside sign: Trailer mobile warning sign parked by road with words for safety by orange cones

Will There Be Changes to FDA’s Post-Approval Changes Guidances?

One of the closing sessions at the recent Association for Accessible Medicine’s GRx + Biosimilars conference covered Post-Approval Changes to Complex Generic Drugs.  The session included presentations from multiple individuals from FDA, as well as from industry, to provide a breadth of perspective on this subject. As one would expect, the session did offer both […]

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11
Nov

Nitrosamines – Where Are We Now?

Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned?  That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference.  The session devoted […]

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09
Nov

CDER Advisory Committee Votes to Progress Quality Management Maturity

Is a mature pharmaceutical quality system really a competitive advantage?  The industry held this as a belief, but progress in a tangible program was always elusive.  On  November 2nd, the CDER’s advisory committee, Pharmaceutical Science and Clinical Pharmacology Advisory Committee (PSCP‑AC), voted to establish a Quality Management Maturity (QMM) program to incentivize investments in mature […]

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03
Nov

Activities Report of the Generic Drugs Program – GDUFA II Quarterly Performance

As Lester Holt says at the introduction of the last show segment on NBC Nightly News – “There’s good news tonight”.  The same might be said of the recently released GDUFA II Quarterly Performance Report (here). The figures for the fourth quarter have some really good news.  First, the number of ANDA awaiting FDA action […]

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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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