FDA Law Blog: Biosimilars

JANUARY 11, 2024

This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of doing business in Puerto Rico.

Pharmaceuticals 59

Pharmaceuticals Licensing Licensing Compliance 59

Practical Cheminformatics

DECEMBER 7, 2023

The Medicinal Chemistry Gordon Research Seminar ( GRS ) provides a condensed version of ResMed. It should be noted that not all biotechs skimp on software licenses. Find mentors from other disciplines who can help you learn. Attend courses; the Drew University ResMed course is a great place to start. Ask a lot of questions.

Computational Chemistry 86

Computational Chemistry Pharmacokinetics Drugs Pharmaceutical Companies 86

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40