Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g.,

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. November is packed with regulatory and industry meetings.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. Overall, 2022 phenylephrine retail sales reached $1.8 billion, compared with retail sales of $0.5

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Agency IQ

OCTOBER 20, 2023

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. In September 2022, the FDA held a workshop focused on increasing the efficiency of biosimilar development programs.

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Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. The Office continues work on a broad array of projects, though not all have been active OCE pursuits.

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The Anticancer Fund

JUNE 7, 2022

10 June 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Clinical investigation of this approach, particularly with respect to the sequencing of chemotherapy and immunotherapy, is warranted. It is one of the focus areas of the Anticancer Fund.

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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 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The December calendar is packed with regulatory and industry meetings.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Alta Sciences

JULY 31, 2024

Dr. David Nguyen , General Manager and Medical Director of Altasciences’ Los Angeles clinical pharmacology unit, says: “Having a diverse medical team working with a diverse participant population can lead to a rewarding experience for both. Discover how drug developers, researchers, and regulators are ensuring this happens.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Agency IQ

FEBRUARY 15, 2024

Draft published December 2022. CDRH Final 12/29/2023; overdue FDA must issue final guidance no later than one year after the close of the public comment period for the draft guidance.

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Drug Target Review

NOVEMBER 27, 2024

Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). 2022 Apr 26;9:878942. Cancer research.

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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. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

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