Entries from HEALTH LAW SECTION BLOG tagged with 'clinical trials'

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A Draft Guidance for Industry about Medication Guides and REMS has been published for comment purposes (February 2011); the draft Guidance indicates that it is intended to address 2 topics pertaining to Medication Guides for drug and biological products-that...

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A Draft Guidance for Industry about Medication Guides and REMS has been published for comment purposes (February 2011); the draft Guidance indicates that it is intended to address 2 topics pertaining to Medication Guides for drug and biological products-that...

Gov. Paterson proclaims Oct 6 as Stem Cell Awareness Day in NYS

Governor David A. Paterson proclaimed October 6, 2010, as Stem Cell Awareness Day in New York State. In part the Proclamation stated that the entire medical community looks forward with much hope and optimism to a future that brings even...

Stem Cell Review -current perspectives

Courtesy of ISSCR's newsletter (The Pulse), the Stem Cell Review (1) is a 10-part series,via videos, that focus on the state of stem cell science today, including medical applications and the business of stem cells. The videos can be accessed...

1/23/09 World's first HESC-based therapy in man by Geron

Big News Release from Geron's Website:1/23/09 Geron Corporation (1) announced that: the FDA has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables...

Some NIH tips on finding reliable health information online

'Finding Reliable Health Information Online' , a webpage from an NIH educational initiative provides tips with links (1), and presents a good organizational tool to frame a health info query. For example, in relating back to an orphan drug inquiry,...

Human Clinical Trials,Marketing Authorization for Pharmaceuticals-ICH

From FDA/CBER, Sept 4, 2008, a follow up on an ICH Harmonised Tripartite Guideline document, 'Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals' (M3(R2) Current Step 2 version dated 15 July...

COI- a topic of intense current importance to NIH

From the front page of the 'NIH Record' dated July 25, 2008, (1) a new story about the Ethics Grand Rounds (2) called on NHLBI's (National Heart, Lung, and Blood Institute) Dr. Nancy DiFronzo and the University of Pennsylvania’s Dr....

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...

Do we want more cancer patients on clinical trials?

June 3, 2008 Andrew J.Vickers of MSKCC (1) shares his personal perspective from his experience working in a major cancer center in the USA (although other authors have drawn similar conclusions) [It] is for the reader to judge the degree...

HIPAA in Research-Institute of Medicine (IOM) project underway, others

From IOM's website-chock full of important projects (1): IOM's Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule- is investigating the effects on health research of the Privacy Rule regulations implementing the Health Insurance Portability...

How do we know? Reported Trials of China, RCTs, the CONSORT Statement

A recent "Trials" paper (authors from China, UK ) [critically evaluates] RCTs conducted in China based on studies published in 2004... to describe their general characteristics, evaluate the quality of their reporting and evaluate their conduct where adequately reported.(1)...

Gene therapy: "...Keeping an eye on clinical trials 2008"

Here is a good article that describes important aspects of a clinical trial strategy in addition to discussing briefly the nature of the study--from Nature on line: 2008 promises to be an exciting one for ocular gene therapy. 2007 saw...

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...

FEB. 26! Stem Cell Experts and NYS Lt. Gov. Paterson to participate in 3rd Annual Stem Cell Summit

See the Feb. 19 press release of RRY Publications announcing keynote speakers at the 3rd Annual Stem Cell Summit at the Hilton New York, NYC on Feb. 26. NYS Lt. Gov. Paterson has been a stem cell proponent and he...

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...

Quality in FDA-Regulated Clinical Research

With eager anticipation of the excellent educational content provided at the Section (and Committee) meeting events scheduled for this year's NYSBA Annual Meeting (Jan 28-Feb 2), I noted that our Health Law Section will focus on "Medical Malpractice, Quality Assurance,...

Clinical Trial Patient Has Hospital-Patient Relationship

Sosnoff v Jackman 2007 NY Slip Op 08439 (November 7, 2007) Appellate Division, Second Department [T]he Supreme Court erred in determining that the Hospital established the absence of any hospital-patient relationship. There is evidence in the record that when 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...

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