FDA Latest Industry Guidance for Liposome Drug Products

Creative PEGWorks

Liposome Drug Products
Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
It provides specific labeling requirements for liposome versus pegylated liposome.
The nonproprietary name of a drug product approved under the Federal Food, Drug, and Cosmetic Act is its established name, which , in most instances , will be the United States
Pharmacopeia (USP) drug product monograph title for that product. If there is no USP monograph for the liposome drug product, you should refer to 21 CFR 299.4, USP General
Chapter <1121> Nomenclature, and the USP Nomenclature Guidelines. The liposome drug product nonproprietary name should include terminology to express that the product is a liposome or a pegylated liposome. Examples:
[DRUG] Liposome Type X [DOSAGE FORM]
[DRUG] Pegylated Liposome Type X [DOSAGE FORM]

View original post

Advertisements
This entry was posted in Blogs. Bookmark the permalink.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s