Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 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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Conversations in Drug Development Trends

JUNE 21, 2024

Clinical researchers are currently working to streamline TIL production and enhance treatment outcomes by more efficiently regulating immune responses — such as combination therapy with checkpoint inhibitors. Check out this webinar on navigating the landscape of oncology clinical trials. Interested in hearing more insights from Matt?

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Perficient: Drug Development

JULY 3, 2023

Recently, Coveo hosted a webinar discussing the importance of HIPAA compliance in the digital world. Coveo’s platform is designed to meet stringent security standards, helping healthcare organizations comply with HIPAA regulations.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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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FDA Science Regulations Production 40

Perficient: Drug Development

OCTOBER 4, 2023

Environmental Sustainability Demands: Develop eco-friendly products or services and highlight your commitment to sustainability as a unique selling point. Global Expansion Challenges: Identify overseas markets with high growth potential and adapt your strategy to cater to local preferences and regulations.

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Compliance Government Production Regulations 52

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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FDA Science Regulations Production 40

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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

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.

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FDA Science Regulations Production 40

Agency IQ

NOVEMBER 3, 2023

BY LAURA DIANGELO, MPH | OCT 30, 2023 9:38 PM CDT FDA’s new proposed rule on the regulation of laboratory developed tests An incredibly quick background : Laboratory developed tests (LDTs) are considered a subset of in vitro diagnostics (IVDs). IVDs are regulated as medical devices in the U.S., Quick intro: QSR, QMSR.

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Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. OPEQ is organized into eight “Offices of Health Technology” (OHTs), which are structured by therapeutic area (e.g.,

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FDA Laboratories Regulations Clinical Trials 40

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.

FDA 40

FDA Science Regulations Production 40

Drug Target Review

DECEMBER 5, 2024

Access to fast, high-throughput tools during the manufacturing process will accelerate the development of therapeutics while adhering to regulations and stringent quality standards. She is a recognised expert in chromatography and protein purification, and serves as a regular panellist at conferences, seminars, and webinars.

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Therapies Virus DNA Compliance 52

Perficient: Drug Development

JUNE 26, 2024

Legal Compliance: Adhering to accessibility standards and regulations, such as the Americans with Disabilities Act (ADA) and Web Content Accessibility Guidelines (WCAG), is a legal requirement that promotes equal access. Ensuring that individuals with auditory disabilities can access information equally is a fundamental aspect of inclusivity.

Compliance 40

Compliance Regulations Research 40

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

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Regulations Compliance Production Nurses 64

Perficient: Drug Development

NOVEMBER 15, 2024

election results could significantly shift healthcare policy and impact healthcare access, affordability, regulation, and innovation. Strict regulations around HIPAA, PHI, and PII create significant barriers, making it difficult to adopt off-the-shelf AI solutions from fields like commerce or digital experience.

Regulations 52

Regulations Compliance Production Nurses 52

Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. In an effort to further explain its current views on potency assurance, the FDA also recorded a webinar to accompany the new draft. The new draft guidance can be broken into three main parts.

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Production FDA Therapies Biochemical Assays 40

Conversations in Drug Development Trends

MAY 1, 2024

Early and Ongoing Engagement Will Save Effort During Your Oncology Clinical Trial Early and ongoing engagement with regulatory agencies is invaluable; initiating dialogue early in the development process facilitates a clearer understanding of regulatory requirements and expectations and builds a relationship with regulators.

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Clinical Research Trials Clinical Trials Research 69

The Pharma Data

DECEMBER 15, 2020

Company plans to meet with regulatory authorities as it evaluates next development steps. Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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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

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

AUGUST 2, 2024

While ASTP/ONC’s work is likely to be higher-level than FDA’s, the strategic plan on AI could, depending on its development, roll down to FDA policy. The HHS announcement also comes with a note that the Department will be hosting a webinar about federal workforce opportunities in this area.

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Agency IQ

JULY 22, 2024

While the agency has been working to implement its rule, which has broad-reaching impacts for diagnostics and drug developers, other moves by the Supreme Court and legislators could impact the agency’s next steps. AgencyIQ provides a status update for regulated industry. diagnostic products are regulated as medical devices.

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FDA Laboratories Regulations Clinical Trials 40

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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