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.

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The Pharma Data

SEPTEMBER 1, 2020

Dive into Medidata’s white paper to find out the best practices and new testing methods clinical trial sponsors are using to immerse patients into clinical trials for a better patient experience and for more enhanced data quality. Download your copy today to find out how to digitally transform your clinical trials. .

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FDA Law Blog: Biosimilars

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Over the years we have blogged many times on the twists and turns of the efforts to regulate LDTs. And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

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Regulations FDA Laboratories Drugs 56

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 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.

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Agency IQ

NOVEMBER 10, 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.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 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.

Pharmaceuticals 40

Pharmaceuticals Science FDA Production 40

Agency IQ

MARCH 1, 2024

What we expect the EPA to do in March 2024 In this returning feature, AgencyIQ looks at public data to determine what the EPA is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more. PFAS regulations for drinking water.

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Regulations Compliance Government Production 40

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

Therapies 59

Therapies Engineering Production FDA 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. For further information on how we process and monitor your personal data click here.

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.

FDA 40

FDA Clinical Trials DNA Treatment 40

Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. Read Asimov, a Boston-based company that uses software and a large library of genetic parts to design living cells, published a white paper that explains their technology in more detail. .” Nature Genetics. This review is a good place to start.

Vaccine 52

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Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. Read Asimov, a Boston-based company that uses software and a large library of genetic parts to design living cells, published a white paper that explains their technology in more detail. .” Nature Genetics. This review is a good place to start.

Vaccine 52

Vaccine DNA Engineering RNA 52

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. at 77 (citation omitted).

Production 52

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