A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
4/3/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Vacated
On October 2, 2024, the U.S. Food and Drug Administration (FDA) released guidance in a question and answer format regarding the use of electronic systems, electronic records, and electronic signatures in clinical...more
11/21/2024
/ Abbreviated New Drug Application (ANDA) ,
Cloud Computing ,
Corrective Actions ,
Data Collection ,
Data Management ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Information Technology ,
Policies and Procedures ,
Record Retention
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more
On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services, announced a final rule updating the regulations regarding Opioid Treatment Programs...more
2/12/2024
/ Certifications ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Licensing Rules ,
Medical Evaluation Reports ,
Opioid ,
Public Health Emergency ,
SAMHSA ,
Substance Abuse ,
Telemedicine
In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs...more
12/7/2023
/ Advertising ,
Amended Regulation ,
Direct to Consumer Sales ,
Enforcement ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
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
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule,...more
In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more