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Prescription Drugs Certification Requirements

Mintz - Health Care Viewpoints

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

Bricker Graydon LLP

Certification requirements for Ohio OTPs

Bricker Graydon LLP on

Health care providers who address and treat addiction are frontline responders to the crisis that sees opioid overdose deaths rising across the country....more

Hogan Lovells

To certify or not to certify? FDA has answered the question

Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

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