Agency IQ

NOVEMBER 20, 2023

EPA issues white paper exploring the adoption of structured content and digital pesticide labels FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance The EPA’s Office of Pesticide Programs (OPP) is in the developmental stage of creating a structured pesticide and digital pesticide label.

Regulations 40

Regulations Production Compliance International 40

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S. Next, the U.S.

Regulations 40

Regulations Trials Science Clinical Trials 40

H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

Compliance 59

Compliance Science Regulations Pharmaceutical Companies 59

The Pharma Data

SEPTEMBER 9, 2020

In order to capture and manage large amounts of data while conforming to regulations, laboratories need to transform and be digitalized by unifying data capture and providing an intuitive way of interacting with it. Transition to advanced analytics platforms to accelerate a product’s time-to-market.

Production 52

Production Laboratories Compliance Government 52

Agency IQ

JULY 21, 2023

In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint. completing confirmatory trials).

FDA 40

FDA Clinical Trials DNA Treatment 40

Agency IQ

MAY 10, 2024

The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.” Also this year, the FDA finalized its new rule on overhauling the medical device quality system regulations.

FDA 40

FDA Regulations Compliance Production 40

Agency IQ

JULY 7, 2023

However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.

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Pharmaceuticals Science FDA Production 40