Remove category agency-information
article thumbnail

A New Theory for Gene Ownership

Bill of Health

No doubt her doctors’ behavior was not consistent with today’s standards of informed consent. Or, perhaps more precisely, because few argue that HeLa is really the same thing as Lacks’s tumor cells, did she own the genetic information contained in her tumor? Did she own the cells of her tumor?

Bioethics 261
article thumbnail

New York Doubles Down on Telehealth

NY Health Law

diminished quality of care, increased opportunity to violate scope of practice or informed consent laws, etc.) Patients were enabled to access vital services while minimizing risk of COVID exposure, and some of the concerns about remote healthcare delivery (e.g., seem not to have been a major concern.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

article thumbnail

SQA Regulatory Surveillance Summary 3 | Monthly Update 2021

SQA

generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. European Medicines Agency (EMA) – Biologics.