News & Analysis as of

Required Communications Comment Period

Ballard Spahr LLP

FDIC seeks comment on its communication methods

Ballard Spahr LLP on

The FDIC has issued a request for information that seeks comment on how the FDIC can make its communications with insured depository institutions (IDIs) “more effective, streamlined, and clear.” ...more

Arnall Golden Gregory LLP

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

Troutman Pepper

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

Troutman Pepper on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

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