Remove Compliance Remove FDA Remove Informed Consent Remove US Department of Health and Human Services
article thumbnail

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

article thumbnail

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Executive Health Resources, Inc. , Executive Health Resources, Inc. , United States Department of Health and Human Services , 58 F.4th In 2023, these include United States ex rel. Polansky v. UnitedHealthcare, Inc. , 3d 239 (Cal. Croda Inc. , 3d 191 (Del. C-8 Personal Injury Litigation , 87 F.4th

FDA 105