In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more
2/23/2024
/ Annual Reports ,
Center for Drug Evaluation and Research (CDER) ,
Drug Compounding ,
DSCSA ,
Enforcement ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Noncompliance ,
Quality Control Plan ,
Supply Chain ,
Written Descriptions
Are you licensed to sell in these states?
Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more
7/20/2023
/ Distributors ,
Filing Requirements ,
Healthcare ,
Licenses ,
Manufacturers ,
Marketing ,
Registration Requirement ,
Regulatory Requirements ,
Sellers ,
State and Local Government ,
State Legislatures
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
12/2/2022
/ Clinical Trials ,
Compliance ,
Continuing Legal Education ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Documentation ,
Draft Guidance ,
EU ,
European Data Protection Board (EDPB) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Individual Accountability ,
International Data Transfers ,
Labeling ,
Manufacturers ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Park Doctrine ,
Popular ,
Public Health ,
Regulatory Violations ,
Reporting Requirements ,
Risk Management ,
Schrems I & Schrems II ,
SCOTUS ,
Separation ,
Standard Contractual Clauses ,
Transparency