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PDSA Asks Stakeholders To Join DSCSA Track-And-Trace Governing Body By September

 
• By Joanne S. Eglovitch

But there’s a wrinkle: Many prospective participants cannot budget for the tiered fees until 2020.

Data Transfer
PDSA Wants Members On Data Governance Board

The Pharmaceutical Distribution Security Alliance (PDSA) is issuing a call for members to serve on the governing body of a soon-to-be launched non-profit group to help guide and coordinate a data governance system under the Drug Supply Chain Security Act. 

The group, once up and running, will define a database architecture to ensure that all members of the supply chain...

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More from United States

ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
• By Cathy Kelly

The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
• By Sarah Karlin-Smith

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

ACIP ‘Pivot’ May Mean Variable US Coverage For New Vaccines, Higher Copays

 
• By Cathy Kelly

Clarity on payer responses to controversial vaccine recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices may be coming.

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

More from North America

New CDER Deputy Director Michael Davis Brings Psychedelic Drug Development Experience

 
• By Sue Sutter

Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
• By Michael McCaughan

The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

Price Inflation Rebates: Biden Policies Add Teeth To Trump’s Pharma Tariff Threat

 
• By Cathy Kelly

Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.