On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors. The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward. Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible ...
On November 13, 2014, the Health Resources and Services Administration ("HRSA") announced its plans to abandon the much anticipated "mega-reg" amid questions concerning HRSA's rule-making authority. The "mega-reg" was expected to provide much needed clarity to the 340B drug discount program (the "340B Program") by addressing, among other things, the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility, and criteria for hospital off-site facilities.
HRSA submitted draft regulations to OMB in April 2014 ...
Blog Editors
Recent Updates
- DEA Issues Third Extension to Public Health Emergency Telemedicine Prescribing Flexibilities, Through 2025
- CMS Issuing First Risk Adjustment Data Validation Audit Notices for PY2018 Since the RADV Final Rule
- Just Released: Telemental Health Laws – Download Our Complimentary Survey and App
- HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates
- Post-Hurricane Flexibilities Offered by the U.S. Department of Health and Human Services Through the Centers for Medicare & Medicaid Services