Bioequivalence

17
Apr
Asking FDA to Take Another Look - What’s New with RfR - Lachman Blog

What’s New with Requests for Reconsideration?

On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]

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14
Apr
Do You Trust What Your Drug Applications are Saying - Lachman Blog

Do You Trust What Your Drug Applications are Saying?

Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]

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11
Apr
Game Show Winner

Is the “Price Is Right” Game Over for Many Generic Drugs?

On April 10, U.S. Senators Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Lee (R-UT) reintroduced bipartisan legislation S. 1302 that would prevent the FDA and industry from participating in a protracted guessing game regarding the amount of an inactive ingredient for a subset of generic drugs that are either required by regulation […]

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03
Apr
Bx Rating - Lachman Blog

FDA Issues Notice to Pharmaceutical Companies Regarding the CRO Raptim Research Pvt. Ltd.

On March 28, the FDA issued a notice (here) informing pharmaceutical companies that have submitted in vitro and in vivo bioequivalence studies in applications that were conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India, that it has “identified significant data integrity and study conduct concerns” in certain studies in […]

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12
Mar
A stack of papers labeled fraudulent claims. Insurance fraud and legal investigation.

Fraud Continues in the Clinical Trial Arena – Sponsors Beware

Today, I read an article in Dickinson’s FDA Webview (here; subscription required) titled “Clinical Researchers Plead Guilty to Fraud” that has the following rather chilling opening line: “Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs […]

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19
Dec
Generic Drug Cluster Has a Lot of Muster - Lachman Blog 2

Generic Drug Cluster Has a Lot of Muster!

The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]

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19
Nov
Career of the track - failure concept

The FDA Posts New and Revised PSGs

The OGD posted 29 new and 31 revised product-specific guidances (PSGs) today (see here). The new list of PSGs covers drugs with various dosage forms including tablets, capsules, gels, oral suspensions, intramuscular extended-release suspensions, topical solutions, powders, ointments, other parenteral products and orally disintegrating tablets, and subcutaneous extended-release suspensions. One of the new PGSs for […]

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30
Oct
Reduce risk level or decrease stress anxiety meter, lower danger indicator or scale, reduce from red alert meter to be green chart concept, businesswoman pull meter to reduce risk or stress level.

First Tranche of PSGs Removing BE Fed Study Requirements to Publish Tomorrow

A pre-publication Federal Register notice today (here) announced the first group of product-specific guidances (PSGs) for which the requirement for a fed, in-vivo bioequivalence (BE) study has been removed.  In some instances, the fasting, in vivo bioequivalence requirements were modified such that now only one in vivo study will be required to support a bioequivalence […]

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25
Oct
The FDA Commissioner Takes a Seat with AAM on the Final Day of GRxBiosims Conference - Lachman Blog

The FDA Commissioner Takes a Seat with AAM on the Final Day of GRx+Biosims Conference

On the last day of GRx+Biosims, David Gaugh, Executive Vice President of AAM, had a fireside chat with Robert Califf M.D., commissioner of the Food and Drug Administration. The Commissioner’s comments echoed many of the themes discussed by other industry and FDA participants during the meeting, especially regarding the worry about sustainability of the generic […]

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23
Oct
Day Three of the AAM GRx-Biosims Conference - Lachman Blog

Day Three of the AAM GRx-Biosims Conference

It is the last day of the conference, and we have some highlights for you. In a keynote address, Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director, Center for Drug Evaluation and Research provided a State of the Biosimilars and Generics Program. By the numbers she indicated that in Fiscal Year (FY) 2024 OGD: Has […]

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