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 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 Treatment Trials 40

Codon

APRIL 30, 2023

If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans. Read This paper explains how synthetic biology is regulated in Europe. Note: I’m employed by the company and a co-author on the paper.)

Vaccine 52

Vaccine DNA Engineering RNA 52

Codon

APRIL 30, 2023

If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans. Read This paper explains how synthetic biology is regulated in Europe. Note: I’m employed by the company and a co-author on the paper.)

Vaccine 52

Vaccine DNA Engineering RNA 52

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 Clinical Trials Science 40

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

PPD

NOVEMBER 18, 2024

Effective monitoring of regulatory intelligence comes with big challenges The challenges inherent to PV RI encompass more than just regulatory complexity — though complexity is a major factor, given regulations are continually created, updated or revised, at all levels (regional, national and global), often all at the same time.

Clinical Trials 52

Clinical Trials Regulations Compliance Production 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. Leading Market Technologies, Inc. ,

Production 52

Production Trials International Government 52