pharmaphorum

SEPTEMBER 29, 2022

Although mHealth has been gaining in popularity for at least the past decade, before commercializing their mHealth products, developers must determine whether the product is subject to U.S. If so, developers must develop and execute on a regulatory strategy. Food and Drug Administration (FDA) regulation as a medical device.

Development 104

Development Regulation Production Life Science 104

XTalks

OCTOBER 19, 2023

An assay development scientist combines deep biological and biochemical expertise with practical laboratory skills to develop tests that can answer specific biological questions or drive the drug discovery process. Related: Pharmaceutical Scientist Jobs: What to Know Before Applying What Does an Assay Development Scientist Do?

Scientist 59

Scientist Development Research Compliance 59

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

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

In-Vitro 81

In-Vitro Regulation Manufacturing Licensing 81

Advarra

NOVEMBER 29, 2022

There have been recent signals indicating the Food and Drug Administration (FDA) plans to provide greater support for CGT, addressing key issues continuing to impede their development. Recent Problems in Cell and Gene Therapy Development. Current Regulatory Trends in Cell & Gene Therapy.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). This timing undermines the Agency’s rationale that three years is enough time to come into compliance. By Allyson B. Mullen & Gail H.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

pharmaphorum

JUNE 1, 2021

Proof of concept shows that it is possible to identify microtaggants using smartphone apps, leading the way to software development kits (SDKs) which can be customised for individual companies and products. Recent work has concentrated on developing convenient readers to scan information carried on the microtaggants. Reduce wastage.

Medicine 52

Medicine DNA Pharmacy Production 52