pharmaphorum

SEPTEMBER 29, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

Development 104

Development Regulation Production Life Science 104

Advarra

OCTOBER 1, 2024

Supplies and materials: These include costs for medical supplies (like drugs, medical devices, and other trial-related materials) and laboratory supplies (such as reagents, kits, and other materials for laboratory activities). This often requires using specific electronic data capture systems and adhering to strict protocols.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

XTalks

OCTOBER 19, 2023

This could involve tweaking experimental conditions, changing reagents or redesigning the assay. Regulatory and Compliance Knowledge Having knowledge of the regulatory landscape is particularly relevant in clinical diagnostics or pharmaceutical industries where the assays must meet specific regulatory standards.

Scientist 59

Scientist Development Research Compliance 59

Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. But review issues are not the only problems.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

FDA Law Blog

MAY 19, 2023

Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance. Within 60 days and continuing for 3 years, sponsors will be required to include the results of that testing in the device’s labeling along with details about the samples used for the testing.

Reagent 40

Reagent Genetics Contamination Marketing 40