Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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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. Developing biosimilars is an extensive and expensive process. million (IQR: $18-36.7

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Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

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Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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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. A key fact about the dostarlimab phase 2 trial for LARC: The drug was stunningly effective. months, according to the GSK presentation.

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Agency IQ

JULY 28, 2023

First, an audit of communications and meeting management under the Prescription Drug User Fee Act (PDUFA) Quick background: As AgencyIQ has previously discussed, the FDA collects user fees as part of an essential bargain between regulators and industry. This week, FDA posted several new special notice contract opportunities on SAM.

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Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well). Priority A List.

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Agency IQ

MAY 3, 2024

A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect.

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Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

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Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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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.)

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Agency IQ

MARCH 1, 2024

On March 26, the Supreme Court will hear the case of Alliance for Hippocratic Medicine vs. FDA , a case which calls into question FDA’s authority to make regulatory changes, to be free from unreasonable scrutiny, and to ensure that the abortion drug mifepristone remains both approved and widely available.

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Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

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Clinical Trials Trials Drugs Drug Development 52

New Drug Approvals

APRIL 21, 2025

The DMSO solution of the alkyl bromide were slowly transferred in order to maintaining an internal temperature of 55.05 Methanol is then removed by vacuum distillation at an internal temperature of NMT 35 C. 20] Acoramidis is the international nonproprietary name. [21] Food and Drug Administration. 26 November 2024. .

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Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

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