What evidence FDA requires for drugs and biologics
How FDA evidence standards work for NDAs, 505(b)(2) applications, ANDAs and biologics licenses, including accelerated approval and the animal rule.
Tag: drugs
6 posts
Port filing and testing for drugs imported into China
The port filing, the customs clearance form and the testing that apply to a drug imported into China, with the periods for registration testing.
FDA rules for clinical studies of drugs and biologics
When an IND is required under 21 CFR Part 312, the exemptions, and the informed consent and investigator duties that govern FDA-regulated drug trials.
The four faster routes to drug approval in China
Breakthrough therapy, conditional approval, priority review and special approval for drugs in China, and which of them shortens a review period.
How a drug clinical trial is approved in China
How a drug clinical trial is cleared in China, from the 60-working-day rule and the 30-working-day channel to the filings that replace approval.
China's commercial health insurance list for innovative drugs
What China's commercial health insurance innovative drug list is, which drugs may apply to it, and what a place on the list gives.