The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company.

Sales 40

Sales Production Doctors Doctor 40

FDA Law Blog

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

JANUARY 27, 2021

Avacta has worked with Adeptrix Inc (Beverly, MA, USA) to develop a coronavirus antigen test that combines enrichment of the sample using Affimer® reagents with the analytical power of mass-spectrometry. Beverley, MA) (“Adeptrix”). I look forward to updating the market when we have definitive clinical performance data.”.

Reagent 52

Reagent In-Vitro FDA Approval Containment 52