Entries from HEALTH LAW SECTION BLOG tagged with 'FDAAA'

FDAAA requirements update: drug safety, clinical trials database

A Draft Guidance for Industry about Medication Guides and REMS has been published for comment purposes (February 2011); the draft Guidance indicates that it is intended to address 2 topics pertaining to Medication Guides for drug and biological products-that...

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...

In the spotlight: FDA key initiatives

Today's FDA webpage show key initatives in their 'Spotlight' focus. This provides a nice overview of what is happening here in recent history and links to the respective website that focuses on each initiative. Through specially targeted initiatives, FDA intensifies...

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...

Another context-the Pharmaceutical Business Review newsletter

For stargazers who visit Supra, here is a weekly publication I have found useful over time--it is grounded in business. The 'Business Digest' newsletter from the Pharmaceutical Business Review (1) published weekly, originates in the UK. With due respect to...

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...

Preemption of state liability laws-several current perspectives

The U.S. House of Representatives, Committee on Oversight and Government Reform held a hearing titled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” on Wednesday, May 14, 2008.(1)Chairman Waxman's Opening Statement states in part: FDA approval of...

C. Brown on "Creating a positive culture for children"

From the State Bar News, NYSBA's Annual Meeting Edition (March/April 2008), an article by Cailin Brown on the Presidential Summit, am panel, leads the issue (1) ...Experts shared ideas on breaking the cycle for youth at risk, Cailin Brown reports,...

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...

Genetic testing and the genomic era- perspectives for clinical practice

Zooming in to focus on particular sections of the FDA Amendments Act of 2007, I first took note of Section 1103 of the FDAAA, “improving genetic test safety and quality,” which requires that by July 2008 the Secretary’s Advisory Committee...

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