As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
1/4/2024
/ Advertising ,
Biosimilars ,
Center for Biologics Evaluation and Research (CBER) ,
Clinical Trials ,
Compliance ,
Draft Guidance ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Life Sciences ,
Manufacturers ,
Marketing ,
Medical Devices ,
Medicare ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Standards ,
Research and Development ,
UK
In a previous alert, Too Important To Fail? Further Light on When EU and Non-EU Technology Providers Will Become Subject To DORA, we discussed the EU Digital Operational Resilience Act (DORA). We have also set up a microsite...more
Earlier this year, the European Data Protection Board (“EDPB”) issued additional guidance on the application of the General Data Protection Regulation (“GDPR”) in the area of scientific health research.
In key takeaways...more
3/5/2021
/ Consent ,
Data Protection ,
Data Protection Impact Assessments (DPIAs) ,
EU ,
European Commission ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Member State ,
Personal Data ,
Scientific Research
On 15 January, 2021, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) adopted a joint opinion (“Joint Opinion”) on the draft new sets of Standard Contractual Clauses (“New...more
1/28/2021
/ Data Protection ,
EDPS ,
EU ,
EU Data Protection Laws ,
European Commission ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses
The Advocate General has issued an Opinion which states that the European Commission’s decision, enforcing the Standard Contractual Clauses (SCCs), is valid....more