Posts tagged PDUFA.
Blogs
2 minute read
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
- Patent Infringement Lawsuit Alleges "Piracy" of AI-Driven Medical Technology
- DOJ Civil Division Accelerates Review of FCA Whistleblower Complaints Involving Federally Funded, State-Administered Benefits Programs
- FDA Warns Against “Over-Reliance” on AI Pharmaceutical Manufacturing . . . But How Much Reliance Is Too Much?
- Five Federal Cases Health Care and Life Sciences GCs Should Continue to Watch in 2026
- CMS Announces Nationwide Moratoria on New Medicare Enrollment for Hospices, Home Health Agencies