Novel Drug Approvals – USFDA (2013 to 2018)
Source: fda.gov; EvaluatePharma®, Pharma, Biotech & Medtech HalfYear Review 2018. Evaluate. July2018.
Related Articles
FDA – New Drug Approvals from 2009 to 2018
Total New Drugs were approved by FDA in last 10 years – 356 The maximum number of New Drug Approvals – In 2018 with a…
SOP FOR MICROBIAL LIMIT TEST FOR THE ESTIMATION OF VIABLE AEROBIC MICRO-ORGANISMS
1.0 OBJECTIVE : To laid down procedure for microbial limit test in for the estimation of the number of viable aerobic micro-organisms present…
Pharmaceutical Quality/Manufacturing Standards (CGMP)- US FDA
Below is a sortable listing of Pharmaceutical Quality/Manufacturing Standards (CGMP) Guidances CATEGORY TITLE Pharmaceutical Quality/Manufacturing Standards (CGMP) COMPRESSED MEDICAL GASES GUIDELINE Compliance; Pharmaceutical…
GUIDELINE ON GOOD MANUFACTURING PRACTICES (GMP) IN PHARMA
GMP:- GMPs define a quality system that manufacturers use as they build quality into their products. For example, approved drug products developed and produced…
IND, NDA AND ANDA DRUG EVOLUTION PROCESS
The Federal Food, Drug and Cosmetics act regulated through Title 21 of U.S Code of federal Regulations, requires a new drug to be approved by…
Responses