Back to Search
Start Over
Regulatory Update.
- Source :
- GMP Review; Jul2014, Vol. 13 Issue 2, p14-20, 7p
- Publication Year :
- 2014
-
Abstract
- The article discusses developments in the regulations of the pharmaceutical industry worldwide. It mentions that the European Union has issued several guidelines including the guideline on process validation for the manufacture of biotechnology-derived active substances by European Medicines Agency (EMA). It states several guidelines for pharmaceutical industry issued by the U.S. including Interpreting Sameness of Monoclonal Antibody Products under the orphan drug regulations.
- Subjects :
- DRUG laws
PHARMACEUTICAL industry
MONOCLONAL antibodies
BIOTECHNOLOGY
Subjects
Details
- Language :
- English
- ISSN :
- 14764547
- Volume :
- 13
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- GMP Review
- Publication Type :
- Periodical
- Accession number :
- 110954349