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

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. For more information, please visit www.sagerx.com.

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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. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 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.

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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.” While this notice does not provide information on the contract’s timeframe, AgencyIQ expects it to cover the next few years under PDUFA VII.

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. Shifting from pharmacology, the draft guidance offers input on design of toxicology studies.

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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. Further, it can enable gathering of more specific and comprehensive quality information. Developing biosimilars is an extensive and expensive process.

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Agency IQ

FEBRUARY 23, 2024

Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.” We need to factor those in to think about whether a PRO outcome in a small trial is going to be informative or not.”

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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. For instance, patient information derived from medical records may not be complete or accurate.

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Agency IQ

DECEMBER 1, 2023

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. However, the revision provided much more detail given the amount of information on Covid-19 that was gained between May 2020 and February 2021. drug-drug interactions) and intrinsic factors (e.g.,

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The Pharma Data

FEBRUARY 8, 2021

In our commitment to advance the science and treatment of prostate cancer, these findings will help inform our research efforts in developing novel approaches and combinatory regimens to improve outcomes for these patients.”. v] ERLEADA ® is being studied in five Phase 3 clinical trials. ERLEADA ® IMPORTANT SAFETY INFORMATION.

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The Anticancer Fund

JUNE 7, 2022

Clinical investigation of this approach, particularly with respect to the sequencing of chemotherapy and immunotherapy, is warranted. Subscription Would you like to stay informed about the latest news on drug repurposing in oncology? You can easily subscribe to this newsletter by clicking here.

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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. FDA provided information on the comparative sales of cold medicines in the U.S.

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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.

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Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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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

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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The Pharma Data

NOVEMBER 9, 2020

He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse. Media Inquiries: MC Services AG Julia Hofmann, Andreas Jungfer T: +49 89 210 228 0 E: xphyto@mc-services.eu.

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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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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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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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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). Clinical Pharmacology & Therapeutics.

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