Glossary

Amendment

“[FDA] Information submitted to a pending submission, including additional information or reanalysis of data previously submitted to clarify, revise or modify the application as originally submitted.

  1. Major Amendment – an amendment to an original application, efficacy supplement, manufacturing supplement or resubmission of any of these applications, including biosimilars, that extends the review clock.
  2. Unsolicited Amendment – a submission of information or data not requested by the Agency.”

Source: SOPP 8401.2: Administrative Processing of BLA and NDA Supplements

Resources

Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.

Glossary

The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

Found 370 Results
Page 1 of 2































Arm

















































































































































ICH






























































































































Page 1 of 2