Entries from HEALTH LAW SECTION BLOG tagged with 'adverse events'

Drug regulation and investments in it-the Matrixx case

The ‘Questions’ presented in the Supreme Court case Matrixx Initiatives, Inc. et al petitioners v. James Siracusano, et al (No. 09-1156) vary among the documents filed in the case, illustrating the complexity of 21st century drug regulation and investments in...

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...

FDA's Quarterly Report: products and potential signals of serious risks/new safety information, AERS database.

Sept 5, 2008 FDA announced (1) that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.(2) The drugs have been identified based on a review of...

FDA and The International Conference on Harmonization (ICH) initiatives of the EU, Japan and the US.

From CDER email news today: In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed...

Help for prescription drug/medical products safety: reactive dependence to proactive surveillance

May 22, 2008, HHS Secretary Mike Leavitt announced new FDA/CMS efforts that will complement each other to improve patient safety and the quality of medical care.(1) Read more about the big picture and how CBO sees the Federal government's Activities...

FDAAA-a 5 yr safety plan

Just out: FDA's "Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan" draft document dated March 2008.(1) FDA will use this plan to communicate strategies FDA will follow for using PDUFA IV drug safety resources; communicate our current...

FDAAA of 2007 and "REMS"

From CDER's email news of today: FDA provides Q&A on the Federal Register Notice on Drugs and Biological Products Deemed to Have A Risk Evaluation and Mitigation Strategy ("REMS"). (1) [re: 3/27/08 Federal Register Notice see (2)] FDA is: identifying...

FDA Amendments Act of 2007 Signed Into Law

The White House news reported Sept. 27, 2007 that "the President signed H.R. 3580, the FDA Amendments Act of 2007, which reauthorizes a number of Food and Drug programs including the PDUFA and MDUFA; extends and modifies authorities related to...

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