FDA – Page 4 – Healthy Skeptic

Oct 14 2010

Politico

By Kevin Roche Headlines No Comments

A bipartisan group of House Energy and Commerce Committee members wants the Food and Drug Administration to delay some of its proposed changes to the process of reviewing and approving a wide array of medical devices

Sep 21 2010

Fiscal Times

By Kevin Roche Headlines No Comments

Like other watchdog regulatory agencies, the FDA operates with fees collected from the very companies it is mandated to scrutinize. It’s the old adage of the fox guarding the hen house.

Sep 18 2010

2010 Potpourri XXXIV

By Kevin Roche Commentary No Comments

On the menu for this week's potpourri--savings from wellness efforts for a large employer; drug reimbursement for Medicaid programs; using remote monitoring in a health plan context; the FDA's regulatory…

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Sep 17 2010

Washington Post

By Kevin Roche Headlines No Comments

Federal health experts rejected a highly anticipated weight loss pill Thursday that was thought to offer a safer way to shed pounds than older medications linked to dangerous side effects

Sep 16 2010

Advamed.org

By Kevin Roche Headlines No Comments

FDA is proposing more than 70 changes, some of which could fundamentally alter basic definitions and submission requirements of the 510(k) process which could disrupt the program and delay patient access to needed medical innovations.

Sep 08 2010

eweek.com

By Kevin Roche Headlines No Comments

The Food and Drug Administration is looking into whether smartphone apps that allow patients to monitor their vital signs wirelessly should earn FDA approval before implementation.

Aug 18 2010

Fiscal Times

By Kevin Roche Headlines No Comments

Late last week, the FDA received a letter from Susan B. Komen for the Cure, the pink ribbon-bedecked juggernaut, demanding the agency maintain its approval of Genentech’s Avastin

Aug 18 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

If there’s an American precedent for the medical central planning of ObamaCare, it’s the Food and Drug Administration. Witness a looming FDA ruling that may deplete the drug arsenal for terminally ill cancer patients.

Aug 17 2010

FDA’s Review of the 510(k) Process

By Kevin Roche Commentary No Comments

The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide…

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Aug 12 2010

GAO Report on Genetic Testing

By Kevin Roche Commentary No Comments

Personalized medicine relies on genetic testing for much of its information. Direct-to-consumer genetic testing firms are widespread and a GAO report reveals that much of their work appears shoddy and…

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Aug 05 2010

twincities.com

By Kevin Roche Headlines No Comments

Proposed changes to the U.S. system for regulating medical devices are more objectionable to the industry than some local experts expected.

Aug 04 2010

Wall Street Journal

By Kevin Roche Headlines No Comments

The Food and Drug Administration proposed shoring up medical-device approval rules that have been criticized as lax and inconsistent by consumer advocates and the agency itself

Aug 04 2010

Bloomberg

By Kevin Roche Headlines No Comments

Medical device makers face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners

Jul 29 2010

FCC & FDA

By Kevin Roche Research No Comments

FCC & FDA: A Memorandum of Understanding Between the Federal Communications Commission and the Food and Drug Administration Center for Devices and Radiological Health

Jul 19 2010

Washington Post

By Kevin Roche Headlines No Comments

In briefing documents posted online, FDA reviewers said two follow-up studies recently submitted by Roche failed to show that Avastin significantly extended lives compared to chemotherapy alone.

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