Conversations in Drug Development Trends

FEBRUARY 21, 2024

We recently published a white paper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study. At Worldwide, our early phase team has conducted these studies for over 20 years, gaining invaluable experience and insights into best practices for an AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

PPD

JULY 9, 2024

At present, we have 99% first-cycle approvals, 100% licenses obtained, 100% dossiers validated and over 99% of submission milestones achieved on behalf of our clients. Download our white paper The post FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance appeared first on PPD. Let’s connect.

Compliance 52

Compliance Production Clinical Research Marketing 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

Therapies 59

Therapies Engineering Production FDA 59

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. However, licensed software can be a UCC sale of “goods.” 2021) (citation omitted). citation and quotation marks omitted). 1536, 1542 (N.D.

Production 52

Production Trials International Government 52