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
- OIRA Memo on Agency Deregulation: Implications for Health Care
- Outside Counsel’s Internal Investigations—Including Those Relating to Health Care—Are Privileged and Protected from Disclosure
- Podcast: Current Tailwinds in Women’s Health - What Do They Mean for Your Business? – Diagnosing Health Care
- Novel AI Laws Target Companion AI and Mental Health
- EDPA Ramps Up Its White-Collar Enforcement Framework