The Premier Consulting Blog

NOVEMBER 4, 2023

The test methods need not be provided in the pre-IND meeting documentation; rather, it suffices to have a strategy in place to account for these drug substance-related impurities. The impact of the device on the drug product quality attributes and safety are suitable issues for discussion in the pre-IND meeting.

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Agency IQ

JULY 28, 2023

In a related development, this week, a new FDA guidance document to support development of medical devices to treat opioid use disorder (OUD) inched closer to release. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ]. Read the full AgencyIQ analysis here.

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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. That guidance document was updated in September 2021 to include 25 questions.

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Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) This is what OIRA is currently reviewing. Report will contain information specified in the commitment letter.

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Agency IQ

MARCH 1, 2024

Must also provide list of recommended documentation for AI contracts. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) We’ve also included documents that are actively under White House review – a process which often takes several weeks (or months) to conclude. and the E.C.

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FDA Science Clinical Trials Regulations 40

Agency IQ

JUNE 2, 2023

We’ve also included documents that are actively under White House review, which often takes several weeks (or months). Note: If a link no longer works, it is likely because OIRA has since cleared the document.) This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. In addition, CDER’s guidance agenda only reflects documents that are under development.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

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The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials. A similar draft guidance document for drug development is in process.

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Agency IQ

SEPTEMBER 29, 2023

That will have meant that FDA flagrantly missed its deadline to issue a guidance document related to medical countermeasure submissions and the use of Drug Master Files for platform technologies, which was due June 24, 2022. FDA is also due to revise 24 other guidance documents at that time. This is what OIRA is currently reviewing.

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Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

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Agency IQ

FEBRUARY 23, 2024

The discussions in this workshop incorporated the content of a draft guidance document on the topic released by the FDA in 2023, as well as the information shared in another series of workshops co-hosted by the FDA and the American Society of Clinical Oncology (ASCO), which occurred in 2022 and 2023.

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Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. At the start of the year, FDA published a guidance document, not specific to oncology, on the use of external controls. What’s ahead?

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Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. one major deficiency or 10 or more minor deficiencies) in ways that generally are consistent with current Agency practices.

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Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Key Documents and Dates Unified Agenda of Regulatory and Deregulatory Actions – Spring 2024

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