Entries from HEALTH LAW SECTION BLOG tagged with 'FDA'

Improving Access to Innovative Medical Therapies: new law

In the recently enacted health insurance reform law, The Patient Protection and Affordable Care Act , (3/23/2010: Public Law No: 111-148), Title VII entitled, Improving Access to Innovative Medical Therapies, (1) describes the framework that envisions building a research and...

FDA's DPNM; biometrics and biology

The Division of Personalized Nutrition and Medicine is charged with developing strategies, methods, and resources for improving individual and public health. The need for this Division and research paradigm resulted from data generated by the Human Genome and HapMap projects....

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)...

FTC rescinds its 1966 Guidance: the Cambridge Filter Method on cigarette tar/nicotine yields

Federal Trade Commission (FTC) FYI news of Nov 26,2008: FTC has rescinded guidance issued in 1966 (1). Advertisers who include statements of tar and nicotine yields as measured by the Cambridge Filter method must ensure that such claims comport with...

FDA Rebuffs NY On Single Dose Vials

Newsday reports yesterday: The head of the U.S. Food and Drug Administration has rejected an appeal from New York State's health commissioner to ban the manufacture of multi-dose vials, saying they are an important option for hospitals. In January, state...

FDA Warns Public of Extortion Scam by FDA Impersonators

Public awareness note: FDA news today reports that FDA is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as 'FDA special agents' or other FDA officials. (1) Several instances have been...

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 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...

2 New FDA websites:Health Professionals Website(interactive)+ Andy's Take(issues discussed)

August 2008. FDA recently launched a new Health Professionals web page as part of a larger effort by the agency to increase interactions and communications with health professional organizations. The webpage provides useful, timely, and accessible information to the nation's...

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...

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...

an example: Academic-Industry drug discovery agreement-UK-NV

By way of one example, take a look via the link below at a news brief showing how one global academic-industry collaboration has developed abroad in the sea of change growing in international R&D relationships. Published May 19, 2008, from...

FDA's Cellular, Tissue and Gene Therapies Advisory Committee meets on HESC-derived therapies

Next Thursday, April 10, 2008, FDA's Cellular, Tissue and Gene Therapies Advisory Committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. (1) A Briefing Document is provided, "Cellular Therapies...

"FDA Takes Next Step in Establishing Overseas Presence"

Here is some interesting news from FDA's email news service (3/14/08): ... an important development, the FDA has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the...

SCT decides 8-1: FDA regulated medical devices products; FDA's new Risk Communication Advisory Committee

Following up on Supra Paul's post about the spring medical device conference, the news reported today on the 8-1 S Ct decision in Riegal v Medtronic 06-179 (Feb 20, 2008). See the opinion linked below via the SCOTUS blog for...

The Regeneration Station talks about... ES cell therapies begin clinical testing 08

NYSTEM Funding Committee meets today starting at 1:30 and the Ethics Committee meeting is scheduled for Feb. 22. See their agenda on the NYSTEM website, attend the public meetings or listen in via webcast, the discussions are serious and the...

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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