Regulatory

Unlock Real World Evidence with Pragmatic Data Governance and Quality Practices

August 04, 2020

How companies are leveraging Real Word Evidence to evaluate therapies under real world conditions in a broader population at a lower cost than using Randomized Clinical Trials.

Debate Accelerates Over Who Gets COVID Vaccine First

August 03, 2020

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

Stakeholders Seek Increased User Fee Support for Biologics

July 24, 2020

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

Will FDA Inspections Ever Be the Same?

July 20, 2020

FDA's plans to resume inspections of some US regulated facilities this week are not clear on which sites will be visited and what alternative oversight strategies will apply where on-site inspections are difficult.

Preparing to Share Regulatory Data: 5 Practical Tips

July 08, 2020

Duncan van Rijsbergen highlights key considerations for life sciences companies tackling data quality issues.

Fauci: Industry Will ‘Walk Away’ From COVID Price Controls

July 07, 2020

Pharmaceutical Executive

Stresses the need for fair pricing of therapies, while ensuring access.

How Will COVID-19 Affect the Financing of Healthcare Provision Across the US?

June 29, 2020

As providers and payers exert ever greater pressure on the pharma industry, will they force manufacturers to offer significant pricing concessions and will this become the new normal for the US healthcare system? Brett Gardiner reports.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines & Drugs

June 29, 2020

The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world, with FDA officials communicating more frequently with their counterparts in Europe, Canada, Japan and other nations through established programs and agreements.

Leverage Compliance Activities to Drive Data-Driven Success

June 26, 2020

Xavier Duburcq describes how pharma leaders can convert compliance from a cost center to a critical success factor.

FDA Seeks to Restore Credibility with EUA Revocation for HCQ

June 18, 2020

After revoking its Emergency Use Authorization for medicines thought to treat COVID=19, the FDA is looking to regain credibility.