Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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Drug Discovery World

JUNE 20, 2024

Now, you might wonder: how exactly can these advanced artificial intelligence models propel clinical research forward? In the context of clinical trials, these models can help us add context to insights. Conventional AI models allow us to extract insights from the clinical data but they do lack context.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

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Trials Clinical Trials Regulations FDA 80

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

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Licensing Licensing Pharmacy FDA 52

Vial

FEBRUARY 21, 2024

These companies are equipped with the expertise and resources to lead successful medical device clinical trials. Medical device sponsors often seek out CROs so they can outsource services such as clinical research, site selection, trial design, and regulatory consulting.

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Advarra

JANUARY 10, 2024

There’s no doubt eSource has the potential to streamline the process of clinical research by improving efficient and accurate data collection. However, adopting eSource is challenging for many research facilities. Research sites may elect to collect data using eSource, paper source, or a combination of the two.

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PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Fortunately, leading global regulators have launched key initiatives.

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Clinical Trials Trials Clinical Research FDA 98

Advarra

JUNE 14, 2022

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Compliance with Applicable Regulations. Abiding by the appropriate research regulations is the right thing to do, it’s legally required, and it’s the heart of the IRB’s mission.

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Compliance Regulations FDA Research 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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Clinical Trials Trials Clinical Research Disease 59

Drug Discovery World

JULY 25, 2023

It has been a very busy period recently for paediatric drug development with the release of many guidance documents from two notable regulatory agencies. For the Central Nervous System (CNS), the neonate brain lacks cerebral auto-regulation, and the blood brain barrier is immature and weak thus medications permeate the CNS more easily 3.

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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. Must also provide list of recommended documentation for AI contracts.

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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

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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Agency IQ

AUGUST 11, 2023

Quick background: Optical Character Recognition (OCR) technology systems convert physical, printed, or scanned documents into machine-readable text, as defined by IBM. The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Therapies FDA Clinical Trials Production 52

Drug Discovery World

DECEMBER 8, 2023

The need for cell and gene therapy development standardisation Presently, a total of 3,866 cell and gene therapies are in various stages of development , spanning from pre-clinical research to pre-registration phases. The data needed for analysis takes months to collect and has a high cost.

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Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations.

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Research Clinical Trials Compliance Regulations 52

FDA Law Blog: Biosimilars

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

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Clinical Trials Trials FDA Clinical Research 52

Agency IQ

NOVEMBER 3, 2023

In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research.

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Therapies Science FDA Production 40

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

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Government FDA Biosimilars Regulations 40

The Pharma Data

MAY 6, 2021

Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. Denmark posts guidance on decentralizing clinical trials. Draft Report. .

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Pharmaceuticals Clinical Trials Trials Biosimilars 52

The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. Persons”, as such term is defined in Regulations under the U.S.

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The Pharma Data

OCTOBER 19, 2020

The Company is also engaged in a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to further expand the NBTXR3 development program. Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP).

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Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development. Everyone may use different software systems to manage these documents.

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Clinical Trials Trials Compliance Clinical Research 52

Agency IQ

AUGUST 18, 2023

The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation. government, so FDA’s regulations are technically parallel to HHS’.

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FDA Regulations Trials Research 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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The Pharma Data

NOVEMBER 9, 2020

The Company is also engaged in a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to further expand the NBTXR3 development program. Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP).

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Immune Response Therapies Clinical Trials Treatment 40

Agency IQ

AUGUST 9, 2024

FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far Last month, the FDA published a new draft guidance document on diversity action plans. While the new version of the guidance is greatly expanded as compared to an earlier version from 2022, it has left plenty of important questions unanswered.

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Science FDA Production Trials 40

Advarra

DECEMBER 1, 2022

HIPAA statements are typically provided to participants in one of two ways: Standalone document in addition to the ICF. For clinical research, this may include local researchers sharing the information with a third party, or, in the case of a partial waiver of Authorization, reviewing PHI for recruitment purposes.

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Clinical Trials Trials Regulations Research 52

PPD

JULY 16, 2024

Staying current with PV-relevant regulations and regulatory guidance can be challenging and often requires an FSP PV RI team that spans multiple countries and languages. This includes everything from clarifications sought from individual regulatory authorities to Q&A documents, other professional publications and conference presentations.

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Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. How and What to measure?

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Clinical Trials Trials FDA Clinical Research 52

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Policy-wise, this is still a work in progress.

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FDA Research Clinical Trials Regulations 40

Agency IQ

SEPTEMBER 1, 2023

FDA finalizes guidance on oversight of RWE studies, making several significant changes The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence.

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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. FDA is also due to revise 24 other guidance documents at that time.

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