Christina Markus

King & Spalding

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FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

7/14/2025 / Capital Markets , Compliance , Disclosure Requirements , Drug Approvals , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Regulatory Requirements , Securities Litigation , Shareholders

DEA Proposes New Rules for Telemedicine Prescriptions

Would Require In-Person Examination In Many Prescribing Scenarios - Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more

3/2/2023 / Compliance , Controlled Substances Act , DEA , Health Care Providers , Healthcare , Prescription Drugs , Proposed Rules , Public Health Emergency , Recordkeeping Requirements , Telemedicine

Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements

Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more

8/20/2020 / Civil Monetary Penalty , Clinical Trials , Compliance , Corrective Actions , Department of Health and Human Services (HHS) , Federal Register , Food and Drug Administration (FDA) , Medical Devices , National Institute of Health (NIH) , Prescription Drugs

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