Abstract
Novel technologies continually give rise to products under the regulatory purview of the Food and Drug Administration (FDA). The degree of impact on the FDA’s regulatory deliberations has several determinants. These are delineated, and recombinant DNA is employed as a paradigm of a new technology. Specific areas discussed are: the products regulated by FDA expected to be produced by recombinant DNA technology: intra-Agency jurisdiction for the various products; scientific and regulatory issues surrounding the products; and sources of the intra-Agency expertise in this area.
- Received August 17, 1982.
- Accepted August 30, 1982.
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.
Log in using your username and password
Log in through your institution
Purchase access
patientACCESS
In This Issue
Jump to section
Related Articles
Cited By...
- No citing articles found.