PPD

OCTOBER 12, 2023

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

PPD

JULY 9, 2024

A unique flex hub model that delivers global solutions at scale At the PPD clinical research business of Thermo Fisher Scientific , a typical FSP RA engagement designates a single team to provide oversight across a client’s many products and throughout all their markets. Let’s connect.

Compliance 52

Compliance Production Clinical Research Marketing 52

Eye on FDA

NOVEMBER 18, 2021

Media coverage regarding the nomination has been largely focused on concerns expressed by some about Dr. Califf’s past work with pharmaceutical companies in clinical research. How will a new commissioner restore confidence in the advisory committee system for both the public and research community?

FDA 57

FDA Pharmaceuticals Pharmaceutical Companies Clinical Research 57

Agency IQ

FEBRUARY 21, 2024

As other health authorities started to require data standards, some, such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) decided to opt for CDISC for regulatory submissions. CMS in the United States ).

Science 40

Science Regulations International FDA 40

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. Medicis Pharmaceutical Corp. , vs. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2917651 (Pa. Paddock Pool Construction Co. , Accord Kreves v.

Production 52

Production International Trials Government 52