FDA Law Blog: Biosimilars

JULY 2, 2025

Specifically, manufacturing/testing procedures and compliance with cGMPs. Conducting internal investigations and audits of manufacturing facilities for compliance with 21 CFR 211/600. Preparing for and responding to government inspections and other compliance matters. Strong verbal and writing skills are required.

Small Molecule

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

FDA

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

Laboratories

The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

Production

Vial

APRIL 10, 2024

Importantly, unlike IQVIA, Vial’s EDC is entirely developed by an internal software engineering team, reducing vendor dependencies. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

Clinical Trials

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

FDA