PPTA Works with Federal Regulators in the U.S.

Throughout 2020, PPTA engaged with federal regulators in the U.S. to ensure our industry is able to meet the needs of patients worldwide who rely on plasma protein therapies. Letters submitted to the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration are linked below:

U.S. Department of Health and Human Services

Request for Information (RFI) to Assist the Department in Identifying Redundant, Overlapping, or Inconsistent Regulations (December 2020)

Request for Information (RFI) Response: Regulatory Relief to Support Economic Recovery (December 2020)

Request for Information (RFI) Response: Advisory Committee of Blood and Tissue Safety and Availability (ACBTSA) – Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) Sec. 209 (June 2020)

U.S. Food and Drug Administration

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Diseases by Blood and Blood Components; Draft Guidance For Industry (March 2020)