Clinical Trials

News & Analysis as of

Health Alert (Australia) - February 1, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Administrative Appeals Tribunal 22 January 2016 - JLSP and Innovation Australia [2016] AATA 23 This...more

FDA-regulated industries: Plan now for these changes in 2016

In our last post, Life Sciences Decoded took a look at new food industry regulations that will roll out in 2016 under the FDA’s Food Safety and Modernization Act. But it’s not just the food industry that will need to prepare...more

It Proved Impossible to Do What the Doctor Ordered...and that Still Hurts

I can remember the morning but not the year – it was around 1999 or 2000 -- when my boss, Al Minahan, and I drove from downtown to Brookline to meet a prospective client. We had an appointment with a recently retired surgeon...more

Ministry of Health of Ukraine amends the procedure for conducting clinical trials of medicinal products (Ukrainian)

On December 31, 2015 the changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the Procedure), have become effective. Below you can review the...more

Ministry of Health of Ukraine amends the procedure for conducting clinical trials of medicinal products

On December 31, 2015 the changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the Procedure), have become effective. Below you can review the...more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

Alert: China Food and Drug Administration Offers Guidance on Clinical Trial Exemptions for Medical Devices

The "Administrative Measures for the Registration of Medical Device" (Registration Measures) was issued by the China Food and Drug Administration (CFDA) and became effective on October 1, 2014. According to the Registration...more

HHS Recognizes Changing Environment of Research: Still Time to Comment

Late last month the Department of Health and Human Services (HHS) and other Federal Departments and Agencies announced an extension until January 6, 2016 to the comment period for the Federal Policy for the Protection of...more

It’s About Time (But Not Quite Yet)

The comment period for the Notice of Proposed Rule Making (NPRM) regarding proposed changes to the Human Subjects Protection “Common Rule” issued by 16 federal departments and agencies in September has been extended an...more

Healthy Holidays From the FTC: Reminders from the FTC to Keep Health Advertising Claims Healthy

Late last week, the FTC Business Center Blog posted a short but important entry on health-related advertising representations entitled 5 principles to help keep your health claims healthy. This friendly reminder highlights...more

Telemedicine Going Global in 2016

International markets – particularly developing countries with a need for the depth of expertise offered by U.S. health care providers – will play a significant role in driving telemedicine growth and continued health care...more

The Food and Drug Administration Announces a Stay Related to IND Guidance

On October 30, 2015, the Food and Drug Administration (FDA) announced in the Federal Register a stay of certain portions of a September 2013 final guidance for clinical investigators, sponsors and institutional review boards...more

Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more

FDA Partially Stays Controversial Policy of Requiring INDs for Clinical Studies Evaluating Food, Dietary Supplements and Cosmetics

On Friday, October 30, 2015, FDA issued a Federal Register notice announcing a partial stay of the agency’s controversial Final IND Guidance entitled, “Investigational New Drug Applications—Determining Whether Human Research...more

No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech

Halloween has come and gone. The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest. There was ample candy –...more

What To Do About Junk Science That’s Published?

We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes...more

President Obama Signs Bills to Amend ACA Small Employer Definition, Expand Access to Clinical Trials

On October 7, 2015, President Obama signed into law H.R. 1624, which amends the Affordable Care Act’s (ACA) definition of “small employer” by maintaining the definition of a small group market as 1-50 employees and thus...more

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

US v Bayer: Randomized Clinical Trials not Required for Dietary Supplement Structure Function Claims – Key Takeaways

In a much anticipated opinion for the dietary supplement industry and for products making health benefit statements, the District of New Jersey in US v. Bayer has found in favor of Bayer in holding that the government failed...more

“Ensuring Access to Clinical Trials Act” Sent to President

On September 28, 2015, the House of Representatives approved by voice vote S. 139, the Ensuring Access to Clinical Trials Act. This legislation would allow individuals to participate in clinical trials for rare diseases...more

OHRP to Host Oct. 20 Meeting on Proposed Overhaul of Common Rule

On October 20, 2015, the HHS Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is hosting a public town hall meeting to respond to questions related to its September 8, 2015 proposed...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

Washington Healthcare Update

This Week: Congress Avoids a Government Shutdown... House and Senate Approves Measure to Expand the Affordable Care (ACA) Act Small Group Market to 100 Employees...Affordable Care Act (ACA) Health Insurers to Receive Only...more

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

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