Stephanie Agu

Hogan Lovells

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FDA’s creation of public database of 200 Complete Response letters raises questions

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

7/11/2025 / Biotechnology , Disclosure Requirements , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements , Securities Litigation

HHS rescinds policy regarding notice-and-comment rulemaking – implications for health care industry

On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more

3/4/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Federal Contractors , Medicaid , Medicare , Regulatory Reform , Regulatory Requirements

DEA proposes revised rules for identifying and reporting suspicious orders of controlled substances

Last week, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled Substances Act. ...more

11/2/2020 / Comment Period , Controlled Substances , Controlled Substances Act , DEA , Drug Distribution , Narcotics , Regulatory Requirements , Suspicious Activities

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