Legal & Regulatory

Recent FDA actions may finally usher in access boost to follow-on biologics in the US

FDA’s recommended guidance is for a system that ‘does not exist, cannot be built by 2023, and poses unacceptable security and compliance risks,’ says alliance

Plan aims to offset costs associated with proposed social and health initiatives

In-house center eliminates the need for a contract manufacturer, company says

Open-to-the-public workshops begin on July 28

Biden’s executive order targets drug pricing, healthcare costs and health insurance practices

Exploring RCT, RWE and alternative study designs as a path forward

Barcode assessment project demonstrates the ground gained in meeting serialization-readiness requirements for supply chain transparency

“Aggregation” and “inference” are specifically allowed, under draft guidance

Pair of life-sciences data powerhouses are immersed in dispute over their respective data services for pharma sales and marketing

The drive for “vaccine equity” around the world is strengthening efforts to limit patent protections on innovative drugs and vaccines to combat Covid

Proposal also points to need for further resource investment to “enhance” FDA operations

Pfizer is working with local law enforcement to counter the threat

The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production

Open Credentialing Initiative (OCI) brings together multiple DSCSA software vendors

The key trends and considerations for specialty providers navigating a changing policy landscape

More leverage for community-based pharmacies and rules changes for drug-pricing reporting

Case study on closing the gap between new specialty drugs and specialty pharmacies

The evolving topics to keep a close watch on in the coming months

The commission is launching a broad review of drug-company mergers to explore how such deals can potentially harm industry competition

While clock now ticking for life sciences companies to comply with the new data standards, opportunities in the offing to simplify manufacturing and the supply chain

Multiple patents contribute to a robust portfolio; however, each patent that issues can potentially become a landmine to another

Go-to safeguards for manufacturers in avoiding mismanagement of their business-central records

Building in the right processes and support for data quality, standards, and governance

Report on member-distributor performance metrics for 2019