Drug Discovery World

JANUARY 30, 2024

To achieve this, we need greater collaboration between academia, therapy developers and manufacturing equipment developers.” Stella Vnook , CEO, Likarda , notes that a s more regenerative therapy options come to the market, patients will demand access to the treatments, often using the court system. She

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. There was no fanfare for this momentous “birth.” These products are subject to the same regulatory requirements as any unapproved medical device”).

In-Vitro 98

In-Vitro Regulation Compliance Production 98

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. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81

The Pharma Data

DECEMBER 23, 2020

Marketing Authorization was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. Elsewhere around the world: Avacta Group – U.K.-based Shanghai Haini Pharmaceutical — China’s Shanghai Haini Pharmaceutical Co.,

Drugs 52

Drugs Licensing Licensing Vaccination 52