FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, 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

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. 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). Amanda Conti, AgencyIQ What kind of biologic products entered the market?

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. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

FDA 40

FDA Science Regulations Production 40