Brand & Product Security

Articles

Industry is still scrambling to handle clerical errors of DSCSA transactions.

FDA Finalizes the Definitions of 'Suspect and Illegitimate' Pharma Products 

. He can be reached at nsaraceno@mjhlifesciences.com.

Event—taking place in Indianapolis—places supply chain education at the forefront. 

HDA’s 2023 Distribution Management Conference Dives into DSCSA Specifics and More

The Pulse online service will provide free resources to enable pharmacy to meet drug traceability rules.

NABP Hopes to Fill a Key Gap in DSCSA Compliance: Local Pharmacies

Initiative intends to facilitate regulatory compliance within the pharma distribution space. 




Introducing GDP-UCI: A New Medicines and Vaccines Reform Program 

Meanwhile, PDG issues more DSCSA guidance on data interoperability.

HDA Seeks to Limit FDA Enforcement Discretion of DSCSA Come November, Raising the Burden on Some Manufacturers

Citing FDA’s slow guidance, the American Pharmacists Association is requesting delay in November 2023 DSCSA enforcement.



Pharmacists Push for Delaying DSCSA implementation 

How taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information


Benefits of Structured Content in Preparing Data for Regulatory Submissions

While this concern is causing ripples in the global supply chain, technological and regulatory advances can help address the issue

Drug Shortages: A Chronic Problem, but New Opportunities Present Themselves

Wholesalers continue to worry about manufacturer commitment to timely compliance 

HDA Annual DSCSA Readiness Survey Shows Progress but Gaps Remain 

Steve Gens is the Founder of Gens & Associates.

Following a decade of solid groundwork to modernize regulatory information management in life sciences, leading companies have now shifted their focus to how they might exploit this new digital landscape

Legal & Regulatory