The Pink Sheet | Drug Manufacturers Beg US FDA to Inspect Facilities, but Still Find Difficulties

Cathy Burgess comments on how the U.S. Food and Drug Administration is likely to use remote evaluations to resolve as many issues as possible before returning to onsite inspections of facilities.

Cathy Burgess is quoted on how the Food and Drug Administration might conduct remote inspections of drug manufacturing facilities amid COVID-19.

Cathy Burgess is quoted on how the U.S. FDA’s Center for Drug Evaluation and Research could potentially handle the expiration of COVID-19-related emergency use authorizations it has issued for drug products.

This week, CMS finalized rules on minimum nursing home staffing standards, as well as access and quality standards in Medicaid, and the Federal Trade Commission (FTC) banned private employers from utilizing most noncompete clauses in employee contracts.

This week, CMS released the FY2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Proposed Rule, and Congress held hearings on chronic care and telehealth proposals.