by Prakash Achaary | Nov 29, 2022 | Blog
FDA establishes numerous enhancements to product quality and chemistry, manufacturing, and controls (CMC) approaches in PDUFA VII to facilitate timely access to safe, effective, and innovative new medicines for patients, including: product quality reviews; CMC...
by Prakash Achaary | May 4, 2022 | Blog
The FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. The FDA’s Office of Regulatory Affairs (ORA) is the lead office for inspections and enforcement. ORA...
