Schools with Biomanufacturing courses:  

NC State University    Worcester Polytechnique Institute    

The FDA approved a total of 46 new drugs in 2017, the most since the peak of 59 in 1996. The agency’s Center for Biologics Evaluation and Research (CBER) also granted a number of landmark approvals, including first approvals for gene therapy prudct and two chemieric antigen receptor (CAR) T cell treatments (Nature Reviews Drug Discovery, Jan 2018) “2017 FEDA drug approvals”

Clinical Trials: 

FDA (good for searching clinical trial information and product approval)   Clinical Trial Search (good site to search for current clinical trials being conducted world-wide)

Covid-19 Clinical Trials

Other clinical trials: 

Open Science DB 

European clinical trials register (clinical trils conducted in the EU)

Information on Medicines

FDA (general portal)

Orange Book

FDA label 

DailyMed (drug listings as submitted to FDA)

Drug Safety and Availability (FDA)

Vaccines, Blood & Biologics (FDA)

Evergreen Drug Patent Search (site lists top drugs and patents associated with the drugs)

NDAs, ANDAs, Generic Drugs, Authorized Generic Drugs

FDA Forms (NDA, ANDA, etc). Instructions (for filing out the forms) FDA Form 3542a

Pediatric Exclusivity

Paragraph IV Certifications (FDA)

Authorized Generic Drugs 

FDA Drug Safety Alerts:

Medwatch.   Safety Reporting Portal

Europe:

European Medicines Agency