Entries from HEALTH LAW SECTION BLOG tagged with 'drug safety'

2 Medications used to reduce risk of primary breast cancer

From AHRQ news Jan 14, 2010- New consumer and clinician summary guides on medications to reduce the risk of breast cancer in women are available from AHRQ’s Effective Health Care Program.The clinician guide summarizes the effectiveness and safety of two...

FDA Basics aims to help consumers gain better understanding of agency

From FDA News Jan. 12 2010 (1) FDA unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process. During an online presentation, the chair of the...

Pres. Obama's Weekly Address: 'Reversing a Troubling Trend in Food Safety' new FDA appointments

Pres. Obama's Weekly Address (3/14/09), excerpts from the Blog, White House transcript. The video can be viewed online at www.whitehouse.gov. 'In his weekly address, President Barack Obama announced the appointments of Dr. Margaret Hamburg as Commissioner of the FDA,...

FDA/WebMD collaboration; FDA Co Branding Policy- Consumer Health Info.

FDA and WebMD announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. WebMD, which attracts nearly 50 million unique visitors each month, provides consumers with credible and timely health news and information. (1)...

FDA Steering Committee/Expert Working Groups for ICH on Quality, Safety, Efficacy, Electronic Standards

International Conference on Harmonization (ICH) Public Meeting October 21, 2008, Rockville MD FDA announced a public meeting entitled “Preparation for ICH meetings in Brussels, Belgium” to provide information and receive comments on the ICH as well as the upcoming meetings...

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...

GAO examines FDA oversight of promotion of drugs for off label uses

July 2008, US GAO published, 'Prescription Drugs FDA’s Oversight of the Promotion of Drugs for Off-Label Uses', a Report to the Honorable Charles E. Grassley, Ranking Member on Finance , US Senate. (29 pp + appendices) Drug companies provide medical...

A Trial in South Africa compares effectiveness of a primary care system on nurse-led ART

Published April 23, 2008 in "Trials" (1) an open access article shares a study protocol entitled: "Streamlining tasks and roles to expand treatment and care for HIV: [randomized] controlled trial protocol" Fairal, l, et al. The South Africa Free State...

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...

US House Passes Drug Safety Bill 403-16

On July 11, 2007 the United States House of Representatives passed H.R. 2900, the "FDA Amendments Act of 2007," by a vote of 403 to 16. It improves current drug safety provisions, encourages greater transparency and timeliness in the drug...

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