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 […]
Category Archives: guideline
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Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry: Draft Guidance for Industry PDF […]
FDA & NIH Guidelines of viral vectors (AAV, lentivirus and adenovirus) and gene therapy NIH Guidelines for AAV Lentivirus and Adenovirus Guidance for Gene Therapy Clinical trials-FDA
