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Wellness Programs Draft Guidance

Ballard Spahr LLP

EEOC Proposes Guidance on GINA, Wellness Programs

Ballard Spahr LLP on

The Equal Employment Opportunity Commission (EEOC) has followed up on proposed regulations that it issued this spring on wellness programs under the Americans with Disabilities Act (ADA) with a new set of proposed regulations...more

Morrison & Foerster LLP

FDA Policy On Wellness Products Is Healthy For Industry

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Morrison & Foerster LLP

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Guidance for Low-Risk General Wellness Products

On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more

Foley Hoag LLP

Life Sciences Alert FDA Issues Draft Guidance on General Wellness Products

Foley Hoag LLP on

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “General Wellness: Policy for Low Risk Devices.” The draft guidance carves out a category of products, deemed “general...more

Akin Gump Strauss Hauer & Feld LLP

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

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