FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval
The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).
Brazil’s Anvisa is accepted into International API Inspection Program
Anvisa is accepted as a member of the international API Inspection Programs.
WHO approves emergency use of CoronaVac, Butantan Institute’s vaccine against Covid-19
According to the WHO director-general, the vaccine is considered safe, effective and quality assured with two doses.
Anvisa Approves Unanimously the Emergency Use of Vaccines
Brazil’s EUA procedure assesses the suitability of Covid-19 vaccines for use during the current public health emergency to minimize.