Entries from HEALTH LAW SECTION BLOG tagged with 'CDER'

FDA's Safe Medication Use Initiative

Read about the launching of FDA’s Safe Use Initiative and the dedicated webpage.(1) The Agenda and transcripts of the respective presentations and discussion from the Nov 16-17 CDER public workshop spotlights some of the opportunities in certain drugs, drug classes...

CDER's Drug Shortage Program; more on vaccines

FDA's news regularly reports on drug shortages of medically necessary products that significantly impact public health. From their FAQs webpage (1): The Drug Shortage Program (DSP) program, within the Center for Drug Evaluation and Research (CDER), was established to address...

AERS: a useful tool for FDA

Excerpts from (FDA) CDER news 4/6/09. AERS, the Adverse Event Reporting System,contains over 4 million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here (1) as summary statistics covering data received...

CDER : certain COI aspects+the 1998 perspective.

From CDER's 8/8/08 email news: The Center for Drug Evaluation and Research’s (CDER) recently published/made effective 7/1/2008 CDER’s MAPP 4641.3 ( superseding MAPPs dated 9/23/96 and 3/23/98). This CDER’s MAPP (Manual of Policies and Procedures) published by CDER’s Office of...

FDA /CDERWarning Letters 2008-Bioresearch monitoring program

For purposes of thinking about trends, I found it interesting to take a look at the last 6 months of FDA/CDER Warning Letters resulting from inspections in regard to its Bioresearch Monitoring Program. The Warning Letters show recent and...

Update your CDER bearings

For more information on clinical investigators, protection of human subjects, and regulatory and compliance programs, a recent CDER news item sugggests CDER's "Information for Clinical Investigators" webpage. This webpage provides guidance for conducting clinical trials with investigational drugs and information...

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