Compounding Guidance Creates Subtle Pressure On Traditional Compounders
Executive Summary
FDA will enforce USP standards, a regulatory first.
You may also be interested in...
Compounding Oversight: Could Third-Party Inspection Solve The Problem?
Iowa has contracted with a national pharmacy group to inspect facilities outside its borders. Although the program could serve as a potential model for a nationwide plan, it also could bring several problems.
FDA Compounding Definition Brings States Into Oversight Fold
State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.
Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: