Editing New Drug Application (section)

== Requirements for similar products ==
[[biologic medical product|Biologics]], such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a [[Biologic License Application]] (BLA), rather than an NDA. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, requiring a somewhat different approval process.

[[Generic drug]]s that have already been approved via an NDA submitted by another maker are approved via an [[Abbreviated New Drug Application]] (ANDA), which does not require all of the clinical trials normally required for a new drug in an NDA.<ref>{{cite web|url=https://www.fda.gov/cder/ogd/|title=FDA, CDER Office of Generic Drugs|website=fda.gov|access-date=April 30, 2018|url-status=dead|archive-url=https://web.archive.org/web/20090528175742/https://www.fda.gov/cder/ogd/|archive-date=May 28, 2009|df=mdy-all}}</ref> Most biological drugs, including a majority of recombinant proteins are considered ineligible for an ANDA under current US law.<ref>{{cite web|url=http://pubs.acs.org/cen/coverstory/8038/8038biogenerics2.html|title=C&EN: COVER STORY - BEYOND HATCH-WAXMAN|website=pubs.acs.org|access-date=April 30, 2018}}</ref>  However, a handful of biologic medicines, including biosynthetic [[insulin]], [[growth hormone]], [[glucagon]], [[calcitonin]], and [[hyaluronidase]] are [[grandfathered]] under governance of the Federal Food Drug and Cosmetics Act, because these products were already approved when legislation to regulate biotechnology medicines later passed as part of the Public Health Services Act.

Medications intended for use in animals are submitted to a different center within FDA, the [[Center for Veterinary Medicine]] (CVM) in a [[New Animal Drug Application]] (NADA).  These are also specifically evaluated for their use in food animals and their possible effect on the food from animals treated with the drug.