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 ...
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Recent Updates
- A Step Closer to the Proposed End of the Self-Affirmed GRAS Pathway
- Imports and the DOJ’s Trade Fraud Task Force: Considerations for the Health Care and Life Sciences Industries
- Federal Appellate Court Upholds Mississippi 340B Contract Pharmacy Protections
- DOJ False Claims Act Priorities: Cybersecurity Is Still on the Radar
- DOJ Launches Cross-Agency Trade Fraud Task Force: What Importers and Businesses Need to Know