Category Archives: guideline

EMA COVID-19 vaccines against SARS-CoV-2(2019nCoV) studies for approval guidance

Table of Contents The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. As a public-health body safeguarding medicines in the European Union (EU), EMA will only approve a vaccine for COVID-19 after a thorough evalutation demonstrating the same high standards of quality, safety […]

FDA Guidance of Industy Documents download for new drug discovery,CMC manufacturing, gene therapy and cell therapy| GeneMedi

PDF Download The table below lists all official FDA Guidance Documents and other regulatory guidance. Summary Document(Click to download) Issue date FDA Organization Topic Guidance Status Open for Comment Comment Closing Date on Draft Docket Number Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry: Draft Guidance for Industry PDF […]