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Over The Counter Drugs (OTC) Final Rules

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Venable LLP

SAMHSA Pushes Final Regulations on Buprenorphine and Methadone Telehealth Access for OTPs

Venable LLP on

In a significant stride toward expanding access to addiction treatment services, the Substance Abuse and Mental Health Services Administration (SAMHSA) published, on January 31, its Final Rule allowing telehealth access to...more

Maynard Nexsen

FDA Final Rules Allows Over The Counter Hearing Aids

Maynard Nexsen on

On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule (the “Rule”) that enables adult consumers (18 years of age or older) with perceived mild to moderate hearing impairment to purchase certain...more

Foley & Lardner LLP

Hearing Aids: More Accessible to Consumers After FDA Issues Final Rule

Foley & Lardner LLP on

Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a...more

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