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 ...
Blog Editors
Recent Updates
- The AI Doctor Is Out? How California’s AB 489 Could Limit AI Development in Healthcare
- Complex Billing and Reasonable Interpretations: Jury Was Entitled to Find Fraud in Doctor’s Upcoding of Speedy COVID-19 Tests, Fourth Circuit Says
- Governor Kotek Signs Oregon’s SB 537, Strengthening Workplace Violence Prevention in Health Care
- From Best Practices to Enforcement: Decoding DOJ’s July 29 Anti-Discrimination Guidance
- HRSA Seeks Applicants to Test 340B Rebate Model Pilot Program