FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post

Read the full article: FDA orders manufacturers to study cleaning problems with medical scopes linked to infections - The Washington Post:

"The agency ordered a trio of manufacturers to conduct real-world evaluations on how well health care workers are cleaning and disinfecting the devices and what more might be done to prevent the spread of life-threatening infections.

Known as duodenoscopes, the devices are used in hundreds of thousands of procedures each year in the United States to drain fluids from pancreatic and bile ducts blocked by cancer tumors, gallstones and other conditions. Doctors consider them a key tool in detecting and treating medical problems in a minimally invasive way."

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CMS Issues Sunshine Rule - Applies to Drug and Device Manufacturers

CMS Issues Sunshine Rule:

"The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, "finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children's Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS," the statement explained. "CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.""

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Physician Payments Sunshine Act (the "rule") - the Federal Register pre-publication version
Physician Payments Sunshine Act (the "rule") - the official Federal Register published version

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The Exemptee Institute
The Designated Representative Institute

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FDA Supplement Guidance Not Strict Enough, MD Says

This is pretty controversial stuff, as the dietary supplement industry largely opposes the draft regulation

Medical News: FDA Supplement Guidance Not Strict Enough, MD Says - in Public Health and Policy, FDA General from MedPage Today:

"An FDA proposal to require dietary supplement manufacturers to submit data proving their product is safe doesn't go far enough, according to a physician writing in the New England Journal of Medicine.  

More than 100 million Americans spend more than $28 billion on vitamins, minerals, herbal ingredients, amino acids and other natural products in the form of dietary supplements each year, "assuming they are both safe and effective," wrote Pieter A. Cohen, MD, of Harvard Medical School and the Cambridge Health Alliance. 

But they have no assurance that the products are safe because FDA regulation of supplements is too weak, Cohen wrote in a Perspective piece."

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Read more about this:

FDA Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

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FDA ramps up role as safety sheriff

Updated Oct 10, 2017

The original link broke.

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ONLY IN THE WORLD-HERALD; FDA RAMPS UP ROLE AS SAFETY SHERIFF FOOD MANUFACTURERS AND FARMERS PREPARE

- -  the original post follows below  - -

FDA ramps up role as safety sheriff - Omaha.com:

"The federal Food Safety Modernization Act will result in numerous changes — some large, some small — for food manufacturers and farmers in 2012 and beyond as the Food and Drug Administration continues its slow, steady rollout of new regulations. During the new law's first year, little has changed other than sweeping educational efforts to prepare farmers and food manufacturers for ramped-up federal inspection efforts. The inspections will include more, and increasingly intense, reviews of food safety and health protocols. But for 2012 and beyond, companies are preparing for financial effects. Over the next five years, the FDA is planning to issue more than 50 new rules, add inspectors and ramp up oversight efforts to the tune of $1.4 billion."

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