#cder

What it Means: Processed or shared your personal data unlawfully, constituting a data breach under the UK GDPR. Failed to follow proper court procedures by carrying out enforcement without the required warrant or authority, causing distress. What is UK GDPR? ::::::::::: Legal Grounds for Your Claim: 1 Data Breach (UK GDPR and Data Protection Act 2018): ◦ If the enforcement company or local…

How Drugs are Developed and Approved

The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness. CDER is the largest of FDA’s six centers. It has responsibility for both prescription and…

REMS Report Review Policy Released by FDA

From the desk of FDA- January 16, 2020

The US Food and Drug Administration (FDA) last month published a new Manual of Policies and Procedures (MAPP) that explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports.

In addition to the standard contents, the REMS must have a timetable for the submission of…

FDA to Provide a Rating System for Drug Manufacturers

From the desk of FDA- 25 October 2019

The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages is mooting the idea of creating a new rating system to help drug purchasers, including consumers, in order to better understand the quality management systems in drug manufacturing facilities.

The basic idea here is that the companies were free to disclose the rating given to…